Dentinal HypersensitivityPhase 3NCT05852366
Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity
A Phase 3 study testing Toothpaste Preparation in people with Dentinal Hypersensitivity and Chronic Periodontitis, run by Dr. D. Y. Patil Dental College & Hospital at 1 site in India.
Trial summary
Recently, Herbal formulations have gained wide popularity in management of Dentinal hypersensitivity owing to the additive effects of active anti-inflammatory ingredients like Curcuma longa, Clove oil, Acacia arabica and Spinach leaves in addition to desensitizing ingredients like Potassium nitrate and/or Sodium… Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Dentinal Hypersensitivity, Chronic Periodontitis
- What is being tested?
- Toothpaste Preparation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteIndia
- Study dates
- 15 May 2023to 15 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patient should be in good general health as determined by the Investigator/ medical expert;
- The patient should agree not to participate in any other oral/dental product studies during the course of this study;
- The patient should agree to delay any dental treatment until the study has been completed;
- The patient should agree to abstain from the use of any non-study oral hygiene products;
- The patient should exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
- The patient should agree to return for all scheduled visits and follow study procedures;
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- The patient should have a minimum of 20 teeth
- The periodontal status of the patient should be Mild to moderate periodontitis (AAP classification 1999)
- The oral status of the patient should be as follows:
- Plaque index (Silness \& Löe 1964) >2 Gingival Index (Löe and Silness 1963) >1.5 Modified Sulcus Bleeding Index (Mombelli et al 1987) >1 PPD > 4mm
- The patient should have two teeth with a Schiff sensitivity score > 1 in response to air challenge.
- If these two eligible teeth are located in the same quadrant, they have to be separated by one other teeth.
Who cannot join
- Presence of any condition, abnormality or situation at baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data
- Pregnant females
- Patients having history of Tobacco use
- Patients with Sjögren's disease
- Patients having immune deficiency diseases, i.e., HIV or AIDS
- Patients with poorly controlled diabetes mellitus
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- Patients taking anti TNF-alpha medication for rheumatoid arthritis
- Patients taking anti-inflammatory, analgesic, or psychotropic drugs,
- Patients having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity;
- Patients with a history or presence of kidney disorders, kidney stones, celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients;
- The teeth will be excluded from study measurements if they have deep, defective, or facial restorations; have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis;
- The teeth having endo-perio lesion.
Trial locations and contacts
1 site in 1 country.
India1 site
Dr. D Y Patil dental College and Hospital, Pimpri, Pune
Pune, Maharashtra, 411018
About this study
Official title: Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity Post Scaling and Root Planning in Chronic Periodontitis: A Randomized Controlled Clinical Trial
- Recently, Herbal formulations have gained wide popularity in management of Dentinal hypersensitivity owing to the additive effects of active anti-inflammatory ingredients like Curcuma longa, Clove oil, Acacia arabica and Spinach leaves in addition to desensitizing ingredients like Potassium nitrate and/or Sodium fluoride.
- Jasmate herbal formulations which contains Potassium Nitrate along with aqua, calcium carbonate, sodium cocoyl glutamate, sorbitol 70%, glycerin, curcuma longa, arginine hydrochloride, erythritol, sodium saccharin, hydrated silica, sodium carboxymethyl cellulose, elettaria cardamomum, foeniculum vulgare, melaleuca leucadendra, eucalyptus globules, aloe barbadensis, carnosic acid, zinc oxide, hydroxyapatite, propolis, hippophae rhamnoides, syzygium aromaticum, myrtus communis, sodium benzoate and sodium fluoride7, where such formulations claim to have an anti-inflammatory action which further reduces the DH.
- Efficacy of desensitizing preparations containing the above ingredients, in the form of Jasmate was tested in the laboratory along with BioMin F and results were encouraging with sufficient occlusion of the dentinal tubules in both the groups without statistically significant differences in the results.
- The biocompatibility (cytotoxicity) of Jasmate toothpaste preparation was evaluated in the laboratory by using human gingival fibroblasts at different concentrations. Different tests like cell cycle analysis, apoptosis / necrosis and MTT were done and Jasmate toothpaste preparation showed the lowest cytotoxicity as compared to BioMin F toothpaste preparation. Jasmate toothpaste preparation showed more than 92% of live cells in all concentrations.
- The current randomized controlled clinical trial will be conducted to evaluate safety and efficacy of Jasmate toothpaste preparation in the management of DH post scaling and root planing in patients with chronic periodontitis.
Read the detailed description
- Chronic periodontitis is an immuno-inflammatory disease characterized by inflammation of gingiva, formation of periodontal pocket, loss of attachment followed by alveolar bone destruction.
- In the presence of periodontal pocket various changes take place along the root surface (medial wall) out of which cytotoxic changes is of great importance.1
- The first approach to manage the chronic periodontitis is thorough supra-gingival and sub-gingival scaling followed by root planing to achieve clean, smooth and hard root surface.2
- One of the most common patient centered adverse outcome of scaling and root planing (Phase I therapy) is dentinal hypersensitivity which is of great clinical significance.3
- Dentinal hypersensitivity (DH) is characterized by short, sharp pain arising from exposed dentin in response to stimuli typically thermal, evaporative, tactile, osmotic, or chemical and which cannot be ascribed to any other form of dental defect or pathology.4
- DH leads to both physical and psychological issues for a patient with regards to the type of food selection, maintaining dental hygiene, and beauty aspects and also affects the quality of life.5
- There are various formulations available to manage DH both in-office and at home like potassium nitrate, potassium chloride, strontium chloride, stannous fluoride, hexahydrate, and aluminum, potassium or ferric oxalates and fluorides.6
- One of the common disadvantages of these commercially available formulations is the inadequate depth of penetration leading to partial relief from DH.
- To overcome this bioactive glass containing dentifrices (BioMin F) was introduced having stable hydroxycarbonate apatite crystal precipitaion that occludes the dentinal tubules when bioactive glass comes in contact with saliva.7 Recently, Herbal formulations have gained wide popularity in management of Dentinal hypersensitivity owing to the additive effects of active anti-inflammatory ingredients like Curcuma longa, Clove oil, Acacia arabica and Spinach leaves in addition to desensitizing ingredients like Potassium nitrate and/or Sodium fluoride.
- Jasmate herbal formulations which contains Potassium Nitrate along with aqua, calcium carbonate, sodium cocoyl glutamate, sorbitol 70%, glycerin, curcuma longa, arginine hydrochloride, erythritol, sodium saccharin, hydrated silica, sodium carboxymethyl cellulose, elettaria cardamomum, foeniculum vulgare, melaleuca leucadendra, eucalyptus globules, aloe barbadensis, carnosic acid, zinc oxide, hydroxyapatite, propolis, hippophae rhamnoides, syzygium aromaticum, myrtus communis, sodium benzoate and sodium fluoride7, where such formulations claim to have an anti-inflammatory action which further reduces the DH.
- Efficacy of desensitizing preparations containing the above ingredients, in the form of Jasmate was tested in the laboratory along with BioMin F and results were encouraging with sufficient occlusion of the dentinal tubules in both the groups without statistically significant differences in the results.
- The biocompatibility (cytotoxicity) of Jasmate toothpaste preparation was evaluated in the laboratory by using human gingival fibroblasts at different concentrations. Different tests like cell cycle analysis, apoptosis / necrosis and MTT were done and Jasmate toothpaste preparation showed the lowest cytotoxicity as compared to BioMin F toothpaste preparation. Jasmate toothpaste preparation showed more than 92% of live cells in all concentrations.
- The current randomized controlled clinical trial will be conducted to evaluate safety and efficacy of Jasmate toothpaste preparation in the management of DH post scaling and root planing in patients with chronic periodontitis.
- Conditions
- Dentinal Hypersensitivity, Chronic Periodontitis
- Being tested
- Toothpaste Preparation
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste PreparationDrug
Dentifrice for management of dentinal hypersensitivity
| Study group | Role | What they receive |
|---|---|---|
| Group A (Experimental group): (n=25): Jasmate toothpaste preparation | Experimental | Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Jasmate toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 8 weeks for assessment of the efficacy Receives: Drug: Toothpaste Preparation |
| Group B (Positive Control): (n=25): Bioactive glass based BioMin F toothpaste preparation | Active comparator | Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Biomin F toothpaste (Bioactive glass with Calcium, Phosphate and Fluoride) onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 8 weeks for assessment of the efficacy Receives: Drug: Toothpaste Preparation |
| Group C (Negative Control): (n=25): Placebo toothpaste without any active desensitizing agent | Placebo comparator | Patients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Placebo toothpaste without any active desensitizing agent onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 8 weeks for assessment of the efficacy Receives: Drug: Toothpaste Preparation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dentinal hypersensitivity
Dentinal hypersensitivity score will be measured by Visual analogue scores on a scale of 0 to 10 using Air stimulus
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
15 May 202315 Dec 2023
- First posted10 May 2023
- Study start15 May 2023
- Primary completion15 Jul 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dentinal HypersensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. D. Y. Patil Dental College & Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jasberry Healthcare Pvt. Ltd
- Responsible party
- Principal investigator, D. Gopalakrishnan, Dr. D. Y. Patil Dental College & Hospital
- Investigators
- Dharamarajan Gopalakrishnan, MDS, Ph.D, Principal investigator, DEAN, Professor and HOD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852366
- Sponsor's protocol ID
- DYPV/EC/883/22
- Status last verified
- Oct 2024
- First submitted
- 8 Apr 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Herbal Dentifrice for Management of Dentinal Hypersensitivity Post Scaling and Root Planning in Chronic Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05852366
- Acronym / sponsor ID
- DYPV/EC/883/22
- Conditions
- Dentinal Hypersensitivity, Chronic Periodontitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Dr. D. Y. Patil Dental College & HospitalUniversity, hospital or other
- Collaborators
- Jasberry Healthcare Pvt. Ltd
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Recently, Herbal formulations have gained wide popularity in management of Dentinal hypersensitivity owing to the additive effects of active anti-inflammatory ingredients like Curcuma longa, Clove oil, Acacia arabica and Spinach leaves in addition to desensitizing ingredients like Potassium nitrate and/or Sodium fluoride.
- Jasmate herbal formulations which contains Potassium Nitrate along with aqua, calcium carbonate, sodium cocoyl glutamate, sorbitol 70%, glycerin, curcuma longa, arginine hydrochloride, erythritol, sodium saccharin, hydrated silica, sodium carboxymethyl cellulose, elettaria cardamomum, foeniculum vulgare, melaleuca leucadendra, eucalyptus globules, aloe barbadensis, carnosic acid, zinc oxide, hydroxyapatite, propolis, hippophae rhamnoides, syzygium aromaticum, myrtus communis, sodium benzoate and sodium fluoride7, where such formulations claim to have an anti-inflammatory action which further reduces the DH.
- Efficacy of desensitizing preparations containing the above ingredients, in the form of Jasmate was tested in the laboratory along with BioMin F and results were encouraging with sufficient occlusion of the dentinal tubules in both the groups without statistically significant differences in the results.
- The biocompatibility (cytotoxicity) of Jasmate toothpaste preparation was evaluated in the laboratory by using human gingival fibroblasts at different concentrations. Different tests like cell cycle analysis, apoptosis / necrosis and MTT were done and Jasmate toothpaste preparation showed the lowest cytotoxicity as compared to BioMin F toothpaste preparation. Jasmate toothpaste preparation showed more than 92% of live cells in all concentrations.
- The current randomized controlled clinical trial will be conducted to evaluate safety and efficacy of Jasmate toothpaste preparation in the management of DH post scaling and root planing in patients with chronic periodontitis.
Detailed description
- Chronic periodontitis is an immuno-inflammatory disease characterized by inflammation of gingiva, formation of periodontal pocket, loss of attachment followed by alveolar bone destruction.
- In the presence of periodontal pocket various changes take place along the root surface (medial wall) out of which cytotoxic changes is of great importance.1
- The first approach to manage the chronic periodontitis is thorough supra-gingival and sub-gingival scaling followed by root planing to achieve clean, smooth and hard root surface.2
- One of the most common patient centered adverse outcome of scaling and root planing (Phase I therapy) is dentinal hypersensitivity which is of great clinical significance.3
- Dentinal hypersensitivity (DH) is characterized by short, sharp pain arising from exposed dentin in response to stimuli typically thermal, evaporative, tactile, osmotic, or chemical and which cannot be ascribed to any other form of dental defect or pathology.4
- DH leads to both physical and psychological issues for a patient with regards to the type of food selection, maintaining dental hygiene, and beauty aspects and also affects the quality of life.5
- There are various formulations available to manage DH both in-office and at home like potassium nitrate, potassium chloride, strontium chloride, stannous fluoride, hexahydrate, and aluminum, potassium or ferric oxalates and fluorides.6
- One of the common disadvantages of these commercially available formulations is the inadequate depth of penetration leading to partial relief from DH.
- To overcome this bioactive glass containing dentifrices (BioMin F) was introduced having stable hydroxycarbonate apatite crystal precipitaion that occludes the dentinal tubules when bioactive glass comes in contact with saliva.7 Recently, Herbal formulations have gained wide popularity in management of Dentinal hypersensitivity owing to the additive effects of active anti-inflammatory ingredients like Curcuma longa, Clove oil, Acacia arabica and Spinach leaves in addition to desensitizing ingredients like Potassium nitrate and/or Sodium fluoride.
- Jasmate herbal formulations which contains Potassium Nitrate along with aqua, calcium carbonate, sodium cocoyl glutamate, sorbitol 70%, glycerin, curcuma longa, arginine hydrochloride, erythritol, sodium saccharin, hydrated silica, sodium carboxymethyl cellulose, elettaria cardamomum, foeniculum vulgare, melaleuca leucadendra, eucalyptus globules, aloe barbadensis, carnosic acid, zinc oxide, hydroxyapatite, propolis, hippophae rhamnoides, syzygium aromaticum, myrtus communis, sodium benzoate and sodium fluoride7, where such formulations claim to have an anti-inflammatory action which further reduces the DH.
- Efficacy of desensitizing preparations containing the above ingredients, in the form of Jasmate was tested in the laboratory along with BioMin F and results were encouraging with sufficient occlusion of the dentinal tubules in both the groups without statistically significant differences in the results.
- The biocompatibility (cytotoxicity) of Jasmate toothpaste preparation was evaluated in the laboratory by using human gingival fibroblasts at different concentrations. Different tests like cell cycle analysis, apoptosis / necrosis and MTT were done and Jasmate toothpaste preparation showed the lowest cytotoxicity as compared to BioMin F toothpaste preparation. Jasmate toothpaste preparation showed more than 92% of live cells in all concentrations.
- The current randomized controlled clinical trial will be conducted to evaluate safety and efficacy of Jasmate toothpaste preparation in the management of DH post scaling and root planing in patients with chronic periodontitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Experimental group): (n=25): Jasmate toothpaste preparation | Experimental | Drug: Toothpaste PreparationPatients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Jasmate toothpaste onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 8 weeks for assessment of the efficacy |
| Group B (Positive Control): (n=25): Bioactive glass based BioMin F toothpaste preparation | Active comparator | Drug: Toothpaste PreparationPatients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Biomin F toothpaste (Bioactive glass with Calcium, Phosphate and Fluoride) onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 8 weeks for assessment of the efficacy |
| Group C (Negative Control): (n=25): Placebo toothpaste without any active desensitizing agent | Placebo comparator | Drug: Toothpaste PreparationPatients will be instructed to brush twice daily. Patients will be instructed to apply at least a 1-inch strip of the Placebo toothpaste without any active desensitizing agent onto a soft toothbrush and to brush thoroughly for 2 minutes and expectorate. All patients will be instructed to use only the assigned products and refrain from other dentifrice or mouth-rinse during the trial but will be allowed to continue their normal oral hygiene practices. Patients will use the assigned product for a period of 8 weeks for assessment of the efficacy |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- The patient should be in good general health as determined by the Investigator/ medical expert;
- The patient should agree not to participate in any other oral/dental product studies during the course of this study;
- The patient should agree to delay any dental treatment until the study has been completed;
- The patient should agree to abstain from the use of any non-study oral hygiene products;
- The patient should exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
Key exclusion criteria (12 listed)
- Presence of any condition, abnormality or situation at baseline that in the opinion of the Principal Investigator may preclude the volunteer's ability to comply with study requirements, including completion of the study or the quality of the data
- Pregnant females
- Patients having history of Tobacco use
- Patients with Sjögren's disease
- Patients having immune deficiency diseases, i.e., HIV or AIDS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste PreparationDentifrice for management of dentinal hypersensitivity | Drug | Group A (Experimental group): (n=25): Jasmate toothpaste preparation, Group B (Positive Control): (n=25): Bioactive glass based BioMin F toothpaste preparation, Group C (Negative Control): (n=25): Placebo toothpaste without any active desensitizing agent |
Primary outcome
Change in dentinal hypersensitivity
Time frame: Baseline to 8 weeks
Dentinal hypersensitivity score will be measured by Visual analogue scores on a scale of 0 to 10 using Air stimulus
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dharamarajan Gopalakrishnan, MDS, Ph.D principal investigator
DEAN, Professor and HOD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toothpaste Preparation in people with Dentinal Hypersensitivity and Chronic Periodontitis, run by Dr. D. Y. Patil Dental College & Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dentinal hypersensitivity (time frame: Baseline to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.