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CTRI Number  CTRI/2021/12/038909 [Registered on: 24/12/2021] Trial Registered Prospectively
Last Modified On: 25/09/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   understanding Ayurveda disease conditions and treatment responses 
Scientific Title of Study   Prediction of Ayurveda Prakriti and Vikriti using automatic questionnaire and digital sensors 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R C Satishkumar 
Designation  Associate Professor 
Affiliation  SRM Medical college hospital Research centre  
Address  Coordinator - Interdisciplinary Institute of Indian System of Medicine (IIISM), Head - Drug Testing Laboratory, Directorate of Research, SRM Institute Science and Technology

Chennai
TAMIL NADU
603203
India 
Phone  9884845887  
Fax    
Email  ayursatish@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R C Satishkumar 
Designation  Associate Professor 
Affiliation  SRM Medical college hospital Research centre  
Address  Coordinator - Interdisciplinary Institute of Indian System of Medicine (IIISM), Head - Drug Testing Laboratory, Directorate of Research, SRM Institute Science and Technology

Chennai
TAMIL NADU
603203
India 
Phone  9884845887  
Fax    
Email  ayursatish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R C Satishkumar 
Designation  Associate Professor 
Affiliation  SRM Medical college hospital Research centre  
Address  Coordinator - Interdisciplinary Institute of Indian System of Medicine (IIISM), Head - Drug Testing Laboratory, Directorate of Research, SRM Institute Science and Technology

Chennai
TAMIL NADU
603203
India 
Phone  9884845887  
Fax    
Email  ayursatish@gmail.com  
 
Source of Monetary or Material Support  
Ayur.AI (OPC) Private limited, Villa 2, Abhimanyu homes Reddykuppam Kanathur Chennai - 603112 
 
Primary Sponsor  
Name  SRM medical college hospital research centre 
Address  SRM Kattankulathur Chennai 603203 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
AyurAI OPC Private limited  Ayur.AI (OPC) Private limited kannathur Chennai 603112 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr R C Satishkumar  SRM Medical college hospital research centre  Interdisciplinary Institute of Indian System of Medicine (IIISM), Directorate of Research, SRM Institute Science and Technology, Kattankulathur - 603 203.
Chennai
TAMIL NADU 		 9884845887

ayursatish@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SRM Medical college hospital research centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: PRAMEHAH, (2) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: VATARAKTAM, (3) ICD-10 Condition:M359||Systemic involvement of connectivetissue, unspecified. Ayurveda Condition: AMAVATAH, (4) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, (5) ICD-10 Condition:L088||Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: KUSHTHAM, (6) ICD-10 Condition:K259||Gastric ulcer, unspecified as acute or chronic, without hemorrhage or perforation. Ayurveda Condition: AMLAPITTAM, (7) ICD-10 Condition:G328||Other specified degenerative disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: VATAVYADHIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of various diseases visiting the OPD 
 
ExclusionCriteria 
Details  Pregnancy and lactating females 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Haematological investigations - Complete blood count
 
2. Renal Function Test (RFT) - Serum creatinine (mg/dL), Blood Urea Nitrogen (BUN) (mg/dL)
 
3. Lipid Profile -Triglyceride, Cholesterol, Very Low Density lipoprotein, High Density lipoprotein, Low Density lipoprotein
 
4. Cytokines - TNF- alpha, IFN-gamma, IL-1, IL-4, IL-6, IL-10
 		 Visit 1 - Before start of treatment
Visit 2 - After three months of treatment 
 
Secondary Outcome  
Outcome  TimePoints 
Pulse Plethysmography signals (PPG) – Finger PPG sensor
 
Electrocardiogram (ECG) - ECG (3-leads)

Electroencephalography (EEG) – Single channel EEG
 		 Visit 1 - Before start of treatment
Visit 2 - After three months of treatment 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
Final Enrollment numbers achieved (Total)= "497"
Final Enrollment numbers achieved (India)="497" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/12/2021 
Date of Study Completion (India) 31/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/03/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ayuraiclinicaltrials@gmail.com].

  6. For how long will this data be available start date provided 05-04-2023 and end date provided 04-04-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Primary objective - To identify the Prakriti of the patients, using the Prakriti questionnaire

To evaluate the Vikriti status of the patients, using Vikriti questionnaire and digital devices

Secondary objective - To correlate the determined Prakriti and Vikriti with doctor’s assessment along with clinical and biochemical parameters

Study hypothesis - We hypothesize that the Prakriti and Vikriti assessment by the questionnaire and integrated with ML / AI framework would vary among patients.

We hypothesize that the digital biomarkers extracted from digital devices would vary in patients according to their Prakriti and Vikriti features along with clinical biochemical parameters.   

 
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