Gut HealthNCT05952232
A Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut.
A study testing PA-GH-01, MK-GH-04 and TSH-GH-03 in people with Gut Health, run by Vedic Lifesciences Pvt. Ltd. at 2 sites in India.
Trial summary
The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight individuals experiencing gut issues. Approximately 20 participants aged between 18 and 65 years will be screened for each group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Health
- What is being tested?
- PA-GH-01, MK-GH-04 and TSH-GH-03
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesIndia
- Study dates
- 17 Aug 2023to 27 May 2024
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female individuals with the age ≥18 and ≤65 years with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF)
- Body mass index > 18 and < 29.9 kg/m2
- Individuals with at least once/ week complains of ≥ 3 of following gastrointestinal symptoms since last three months: dyspepsia, diarrhea, constipation, heartburn, nausea, acid reflux, bloating.
- Individuals agreeing to consume four tablets (325 mg each) of aspirin twice within a 12-hour period
- Individuals with fasting blood glucose levels ≤ 125 mg/dL
- Individuals with availability of western toilet at their homes for stool sample collection
- Individuals who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights.
- Individuals who are able to give written informed consent and are willing to participate in the study.
Who cannot join
- Individuals diagnosed with IBS including IBS-Constipation, IBS-Mixed, IBS-Diarrhea or Unclassified
- Allergy to aspirin
- Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin/mineral supplements
- Performing high intensity exercise regularly using IPAQ- SF
- Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening
- Unwillingness to avoid the use of antidiarrheal or laxative medication on a regular or an "as-needed basis" during the full length of the study
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- Abnormal Thyroid Stimulating Hormone (TSH) value which is < 0.40 or > 4.50 μIU/mL
- Individuals with uncontrolled type II DM defined as FBG > 125 mg/ dL
- Presence of uncontrolled hypertension defined as SBP ≥ 140 mm Hg and/or DBP ≥ 90 mm Hg with or without anti-hypertensives
- Individuals on high-fiber/ fodmap diet
- Individuals with known diagnosis of helicobacter pylori infection
- Individuals with a history of surgical resection of the stomach, small intestine or large intestine
- Individuals with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis
- Current smokers
- Use of another investigational product within 3 months of the screening visit
- History or current impaired cardiovascular circulation or uncontrolled hypertension, diabetes, bleeding tendencies, kidney, liver or chronic respiratory diseases including asthma, or any other disease, that by the investigators' discretion could interfere with the intestinal barrier function of the subject
- Individuals who used probiotics, prebiotics, antibiotics, prokinetics, laxatives, suppositories or enemas in the last 3 months
- Individuals with a history of any diet-based intolerance (gluten or lactose intolerance)
- Individuals with a history of or complications from malignant tumors.
- History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
- Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.
- High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men
- Individuals who have clinically significant following illness, i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, other gastrointestinal diseases, etc
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives
- Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Dr. Kumta Mali's Clinic
Mumbai, Maharashtra, 400053
Dr. Preeti Bawaskar's Clinic
Thane, Maharashtra, 400607
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut - a Pilot Study
The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight individuals experiencing gut issues. Approximately 20 participants aged between 18 and 65 years will be screened for each group. All the five arms of the IP and placebo trial arms will each have at least 10 completed participants after accounting for the screening failure and dropout/withdrawal rate of 20% each. The treatment duration for all the study participants will be 29 days.
- Conditions
- Gut Health
- Being tested
- PA-GH-01, MK-GH-04, TSH-GH-03, PA-GH-02
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA-GH-01Dietary supplement
1 capsule after breakfast once a day
MK-GH-04Dietary supplement
1 capsule after breakfast once a day
TSH-GH-03Dietary supplement
1 capsule after breakfast once a day
PA-GH-02Dietary supplement
1 capsule after breakfast once a day
| Study group | Role | What they receive |
|---|---|---|
| PA-GH-01 | Active comparator | 1 capsule after breakfast once a day Receives: Dietary Supplement: PA-GH-01 |
| MK-GH-04 | Active comparator | 1 capsule after breakfast once a day Receives: Dietary Supplement: MK-GH-04 |
| TSH-GH-03 | Active comparator | 1 capsule after breakfast once a day Receives: Dietary Supplement: TSH-GH-03 |
| PA-GH-02 | Placebo comparator | 1 capsule after breakfast once a day Receives: Dietary Supplement: PA-GH-02 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Gut permeability as assessed by the urinary lactulose-mannitol ratio from baseline
Measured: Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Gut protection as assessed by the Aspirin challenge test from baseline
Measured: Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Stool consistency as assessed by Bristol Stool Type from baseline
Measured: Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Gut microbiome as assessed by the fecal pH from baseline
Measured: Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Quality of life as assessed by gastrointestinal quality of life index (GIQLI) from baseline
Measured: Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
The stress level as assessed by change in the Perceived Stress Scale (PSS) from baseline
Measured: Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Appetite regulation as assessed by a Three-Factor Eating Questionnaire-R18 (TFEQ-R18) from baseline
Measured: Day 29
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Motivation to exercise as assessed by VAS score from baseline
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start17 Aug 2023
- Primary completion27 May 2024
- Study completion27 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut HealthStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, Placebo-controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952232
- Sponsor's protocol ID
- EB/230301/TPEKC/LG
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2023
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Feasibility Study to Evaluate Efficacy of Different Natural Ingredients in Improving Gut Health in Adults With Leaky Gut - a Pilot Study
- ClinicalTrials.gov ID
- NCT05952232
- Acronym / sponsor ID
- EB/230301/TPEKC/LG
- Conditions
- Gut Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Aug 2023 (actual)
- Primary completion
- 27 May 2024 (actual)
- Study completion
- 27 May 2024 (actual)
- First posted
- 19 Jul 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.
The present study is a randomized, placebo-controlled, double-blind, parallel group study to assess the gut health effects of IP as compared to a placebo in overweight individuals experiencing gut issues. Approximately 20 participants aged between 18 and 65 years will be screened for each group. All the five arms of the IP and placebo trial arms will each have at least 10 completed participants after accounting for the screening failure and dropout/withdrawal rate of 20% each. The treatment duration for all the study participants will be 29 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Randomized, double-blind, Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| PA-GH-01 | Active comparator | Dietary Supplement: PA-GH-011 capsule after breakfast once a day |
| MK-GH-04 | Active comparator | Dietary Supplement: MK-GH-041 capsule after breakfast once a day |
| TSH-GH-03 | Active comparator | Dietary Supplement: TSH-GH-031 capsule after breakfast once a day |
| PA-GH-02 | Placebo comparator | Dietary Supplement: PA-GH-021 capsule after breakfast once a day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female individuals with the age ≥18 and ≤65 years with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ-SF)
- Body mass index > 18 and < 29.9 kg/m2
- Individuals with at least once/ week complains of ≥ 3 of following gastrointestinal symptoms since last three months: dyspepsia, diarrhea, constipation, heartburn, nausea, acid reflux, bloating.
- Individuals agreeing to consume four tablets (325 mg each) of aspirin twice within a 12-hour period
- Individuals with fasting blood glucose levels ≤ 125 mg/dL
Key exclusion criteria (25 listed)
- Individuals diagnosed with IBS including IBS-Constipation, IBS-Mixed, IBS-Diarrhea or Unclassified
- Allergy to aspirin
- Use of medications in the last 2 weeks prior to the pre-baseline period. This does not include birth control pills or standard multi-vitamin/mineral supplements
- Performing high intensity exercise regularly using IPAQ- SF
- Daily use of NSAIDs in the last 3 months or incidental use in the last 2 weeks prior to screening
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 |
|---|---|---|
| PA-GH-011 capsule after breakfast once a day | Dietary supplement | PA-GH-01 |
| MK-GH-041 capsule after breakfast once a day | Dietary supplement | MK-GH-04 |
| TSH-GH-031 capsule after breakfast once a day | Dietary supplement | TSH-GH-03 |
| PA-GH-021 capsule after breakfast once a day | Dietary supplement | PA-GH-02 |
Primary outcome
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Time frame: Day 29
Gut permeability as assessed by the urinary lactulose-mannitol ratio from baseline
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Time frame: Day 29
Gut protection as assessed by the Aspirin challenge test from baseline
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Time frame: Day 29
Stool consistency as assessed by Bristol Stool Type from baseline
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Time frame: Day 29
Gut microbiome as assessed by the fecal pH from baseline
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Time frame: Day 29
Quality of life as assessed by gastrointestinal quality of life index (GIQLI) from baseline
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Time frame: Day 29
The stress level as assessed by change in the Perceived Stress Scale (PSS) from baseline
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Time frame: Day 29
Appetite regulation as assessed by a Three-Factor Eating Questionnaire-R18 (TFEQ-R18) from baseline
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in
Time frame: Day 29
Motivation to exercise as assessed by VAS score from baseline
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 17 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PA-GH-01, MK-GH-04 and TSH-GH-03 in people with Gut Health, run by Vedic Lifesciences Pvt. Ltd. at 2 sites 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 8 inclusion and 25 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
To assess efficacy of the natural ingredients on gut permeability as assessed by the change in (time frame: Day 29). The study lists 8 primary outcomes in all. 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 17 Jun 2024.