Type2diabetesNCT06167226
Understanding Ayurveda Disease Conditions and Treatment Responses
An observational study of Type2diabetes and Rheumatoid Arthritis, run by Ayurai Private Limited at 1 site in India.
Trial summary
The goal of this observational study is to assess Prakriti \& Vikriti in patients visiting OPD of IIISM department, SRM hospital. The main question[s] it aims to answer are: To evaluate Prakriti \& Vikriti of patients using Prakriti \& Vikriti questionnaire and with digital devices To correlate the determined Prakriti… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type2diabetes, Rheumatoid Arthritis, Osteo Arthritis Knee
- What is being tested?
- Personalized Ayurveda treatment protocol
- How many people
- 497 participants
- Where
- 1 siteIndia
- Study dates
- 29 Dec 2021to 31 Mar 2023
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients of various diseases visiting the OPD
Who may be able to join
- Patients of various diseases visiting the OPD
Who cannot join
- Pregnancy and lactating females
Trial locations and contacts
1 site in 1 country.
India1 site
SRM Medical College Hospital & Research Centre
Chennai, Tamil Nadu, 603203
About this study
Official title: Prediction of Ayurveda Prakriti and Vikriti Using Automatic Questionnaire and Digital Sensors
The goal of this observational study is to assess Prakriti \& Vikriti in patients visiting OPD of IIISM department, SRM hospital.
The main question[s] it aims to answer are:
- To evaluate Prakriti \& Vikriti of patients using Prakriti \& Vikriti questionnaire and with digital devices
- To correlate the determined Prakriti and Vikriti with the doctor's assessment along with clinical and biochemical parameters Participants will be advised to follow the treating physician's advice on medicines
Read the detailed description
The Ayurveda is an ancient documented medical system originated in India. The Ayurveda stratified humans into 7 broad categories based on the phenotype features viz. Vata, Pitta, Kapha, Vatapitta, Vatakapha, Kaphapitta and Vatapittakapha Prakriti types. Also, the features of the disease conditions are clearly described based on the predominance of Vata, Pitta and Kapha or its combinations. Presently, the identification of Prakriti type and Vikriti status are basically subjective assessment. This study proposes to integrate the subjective assessment with objective digital signal parameters. This digital signatures would be useful in ML / AI based assessment and prediction of Prakriti type and Vikriti status of the patients.
- Conditions
- Type2diabetes, Rheumatoid Arthritis, Osteo Arthritis Knee, Skin Diseases, Gastric Ulcer, Neurodegenerative Diseases
- Being tested
- Personalized Ayurveda treatment protocol
- Medical subject headings
- Arthritis, Rheumatoid, Skin Diseases, Stomach Ulcer, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Ayurveda treatment protocolDrug
Also called No other intervention name
The treating physician decided and advised personalized Ayurveda treatment protocol based on disease and patient's condition
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Complete blood count at 12 week
complete blood count, which includes red blood cell count, neutrophil count, eosinophil count, basophil count, lymphocyte count, monocyte count, and platelet count is a standard investigation to measure the abnormality in blood cells
Measured: 12 weeks
Serum Urea
Measures urea, which is a investigation to measure the abnormality in kidney function
Measured: 12 weeks
Serum creatinine
Measures creatinine, which is a investigation to measure the abnormality in kidney function
Measured: 12 weeks
Lipid Profile
Lipid profile test includes Total cholesterol, LDL, HDL, Triglycerides, and non-HDL is a investigation to measure the abnormality in lipids
Measured: 12 weeks
Cytokines (TNF- alpha, IFN-gamma, IL-1, IL-4, IL-6, IL-10)
Cytokines are inflammatory markers, measured to identify treatment effect in inflammation
Measured: 12 weeks
Secondary outcomes (1)
Pulse Plethysmography signals (PPG) - Finger PPG sensor
PPG is measured to identify pulse wave form changes before and after treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start29 Dec 2021
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2diabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ayurai Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SRM Medical College Hospital & Research Centre
- Responsible party
- Sponsor
- Investigators
- RC Sathish kumar, Principal investigator, SRM Medical College Hospital & Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06167226
- Sponsor's protocol ID
- CTRI/2021/12/038909
- Status last verified
- Dec 2023
- First submitted
- 18 Nov 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Ayurveda Prakriti and Vikriti Using Automatic Questionnaire and Digital Sensors
- ClinicalTrials.gov ID
- NCT06167226
- Acronym / sponsor ID
- CTRI/2021/12/038909
- Conditions
- Type2diabetes, Rheumatoid Arthritis, Osteo Arthritis Knee, Skin Diseases, Gastric Ulcer, Neurodegenerative Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Ayurai Private LimitedIndustry (pharma, biotech, devices)
- Collaborators
- SRM Medical College Hospital & Research Centre
- Study start
- 29 Dec 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 12 Dec 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 goal of this observational study is to assess Prakriti \& Vikriti in patients visiting OPD of IIISM department, SRM hospital.
The main question[s] it aims to answer are:
- To evaluate Prakriti \& Vikriti of patients using Prakriti \& Vikriti questionnaire and with digital devices
- To correlate the determined Prakriti and Vikriti with the doctor's assessment along with clinical and biochemical parameters Participants will be advised to follow the treating physician's advice on medicines
Detailed description
The Ayurveda is an ancient documented medical system originated in India. The Ayurveda stratified humans into 7 broad categories based on the phenotype features viz. Vata, Pitta, Kapha, Vatapitta, Vatakapha, Kaphapitta and Vatapittakapha Prakriti types. Also, the features of the disease conditions are clearly described based on the predominance of Vata, Pitta and Kapha or its combinations. Presently, the identification of Prakriti type and Vikriti status are basically subjective assessment. This study proposes to integrate the subjective assessment with objective digital signal parameters. This digital signatures would be useful in ML / AI based assessment and prediction of Prakriti type and Vikriti status of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of various diseases visiting the OPD
Key inclusion criteria (1 listed)
- Patients of various diseases visiting the OPD
Key exclusion criteria (1 listed)
- Pregnancy and lactating females
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 |
|---|---|---|
| Personalized Ayurveda treatment protocolAlso: No other intervention nameThe treating physician decided and advised personalized Ayurveda treatment protocol based on disease and patient's condition | Drug | – |
Primary outcome
Change from baseline in Complete blood count at 12 week
Time frame: 12 weeks
complete blood count, which includes red blood cell count, neutrophil count, eosinophil count, basophil count, lymphocyte count, monocyte count, and platelet count is a standard investigation to measure the abnormality in blood cells
Serum Urea
Time frame: 12 weeks
Measures urea, which is a investigation to measure the abnormality in kidney function
Serum creatinine
Time frame: 12 weeks
Measures creatinine, which is a investigation to measure the abnormality in kidney function
Lipid Profile
Time frame: 12 weeks
Lipid profile test includes Total cholesterol, LDL, HDL, Triglycerides, and non-HDL is a investigation to measure the abnormality in lipids
Cytokines (TNF- alpha, IFN-gamma, IL-1, IL-4, IL-6, IL-10)
Time frame: 12 weeks
Cytokines are inflammatory markers, measured to identify treatment effect in inflammation
1 secondary outcome
Pulse Plethysmography signals (PPG) - Finger PPG sensor
Time frame: 12 weeks
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 21 Dec 2023.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices)
Related trials for Type2diabetes
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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.
RC Sathish kumar principal investigator
SRM Medical College Hospital & Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2diabetes and Rheumatoid Arthritis, run by Ayurai Private Limited 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 1 inclusion and 1 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 21 Dec 2023. 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. 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?
Change from baseline in Complete blood count at 12 week (time frame: 12 weeks). The study lists 5 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 21 Dec 2023.