| CTRI Number |
CTRI/2023/02/049912 [Registered on: 20/02/2023] 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 |
Single Arm Study |
|
Public Title of Study
|
Understanding Ayurveda diseases and treatment responses through AI |
|
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 L Mahadevan |
| Designation |
Chief Ayurveda Consultant |
| Affiliation |
Dr.Y.Mahadeva Iyers Sri Sarada Ayurveda Clinic |
| Address |
Dr.Y.Mahadeva Iyers Sri Sarada Ayurveda Clinic E29, Room no 1, Ayurveda Division, Megawin
Towers, First Floor, 2nd Avenue, Besant Nagar,
Chennai
TAMIL NADU
600090
India
Chennai
TAMIL NADU
600090
India |
| Phone |
9382217268 |
| Fax |
|
| Email |
mahadevan101@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Mahadevan |
| Designation |
Chief Ayurveda Consultant |
| Affiliation |
Dr.Y.Mahadeva Iyers Sri Sarada Ayurveda Clinic |
| Address |
Dr.Y.Mahadeva Iyers Sri Sarada Ayurveda Clinic E29, Room no 1, Ayurveda Division, Megawin
Towers, First Floor, 2nd Avenue, Besant Nagar,
Chennai
TAMIL NADU
600090
India
Chennai
TAMIL NADU
600090
India |
| Phone |
9382217268 |
| Fax |
|
| Email |
mahadevan101@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Mahadevan |
| Designation |
Chief Ayurveda Consultant |
| Affiliation |
Dr.Y.Mahadeva Iyers Sri Sarada Ayurveda Clinic |
| Address |
Dr.Y.Mahadeva Iyers Sri Sarada Ayurveda Clinic E29, Room no 1, Ayurveda Division, Megawin
Towers, First Floor, 2nd Avenue, Besant Nagar,
Chennai
TAMIL NADU
600090
India
Chennai
TAMIL NADU
600090
India |
| Phone |
9382217268 |
| Fax |
|
| Email |
mahadevan101@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayur.AI (OPC) Private limited, Villa 2, Abhimanyu homes Reddykuppam Kanathur Chennai -
603112 |
|
|
Primary Sponsor
|
| Name |
Sri Sarada Ayurveda Hospital |
| Address |
E29, Megawin Towers, First Floor, Ayurveda Division, Room no 1, 2nd Avenue, Besant Nagar,
Chennai-600090 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AyurAI OPC Private limited |
Ayur.AI (OPC) Private limited, Villa 2,
Abhimanyu homes Reddykuppam Kanathur
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 L Mahadevan |
Sri Sarada Ayurveda Clinic |
E29, Megawin Towers,
First Floor, Room no 1,
Ayurveda division, 2nd
Avenue, Besant Nagar,
Chennai
TAMIL NADU |
9382217268
mahadevan101@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Hycare super specialty hospital, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J459||Other and unspecified asthma. Ayurveda Condition: TAMAKASVASAH, (2) ICD-10 Condition:J069||Acute upper respiratory infection,unspecified. Ayurveda Condition: PRANAVAHASROTOVIKARAH, (3) ICD-10 Condition:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: AMLAPITTAM, (4) ICD-10 Condition:K588||Other irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, (5) ICD-10 Condition:M129||Arthropathy, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (6) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: VATARAKTAM, (7) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (8) ICD-10 Condition:M468||Other specified inflammatory spondylopathies. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAMÂ (KEVALAVATA), (9) ICD-10 Condition:G20||Parkinsons disease. Ayurveda Condition: KAMPAH/VEPATHUHÂ (KEVALAVATA), (10) ICD-10 Condition:G379||Demyelinating disease of central nervous system, unspecified. Ayurveda Condition: VATAVYADHIH, (11) ICD-10 Condition:G63||Polyneuropathy in diseases classified elsewhere. Ayurveda Condition: PRAMEHA-UPADRAVAH, (12) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: KITIBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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 |
Pulse Plethysmography signals (PPG) – Finger
PPG sensor
Electrocardiogram (ECG) - ECG (3-leads) |
Visit 1 - Before treatment
Visit 2 - After treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disease symptoms comparison |
Visit 1 - Before treatment
Visit 2 - After treatment |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ayuraiclinicaltrials@gmail.com].
- For how long will this data be available start date provided 01-09-2024 and end date provided 31-08-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Primary objective – 1. To identify the Prakriti of the patients, using Prakriti questionnaire and computer vision techniques 2. To evaluate the Vikriti status of the patients, using Vikriti questionnaire and digital devices Secondary objective - 3. To correlate the Prakriti and Vikriti with clinical, biochemical and digital markers. 4. The ML/AI techniques will be used to train the dataset and to develop an accurate predictive Prakriti and Vikriti algorithm. 5. To effectively optimize the Vikriti prediction algorithm, the retrospective data of last five-year will be collected. |