| CTRI Number |
CTRI/2024/11/076965 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
15/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the causes and etiopathogenesis of obesity, focusing on Ashtadosha and examining the effectiveness of Vidangadi Churna. |
|
Scientific Title of Study
|
To evaluate the Nidan eEvum Samprapti of Sthaulya with special reference to Ashtadosha and its Upshyatmaka Parikshana by Vidangadi Churna |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anandana |
| Designation |
M.D. Scholar |
| Affiliation |
Government Ayurveda PG College and Hospital Chaukaghat, Varanasi, Uttar Pradesh 221002 |
| Address |
Department of Rog Nidan Evum Vikriti Vigyana Government Ayurvedic P G College and Hospital , Chaukaghat ,Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6206825280 |
| Fax |
|
| Email |
anandana1001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deena Nath Singh |
| Designation |
Lecturer |
| Affiliation |
Government Ayurveda PG College and Hospital Chaukaghat ,Varanasi, Uttar Pradesh 221002 |
| Address |
Department of Rog Nidan Evum Vikriti Vigyana Government Ayurvedic P G College and Hospital , Chaukaghat ,Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9415393653 |
| Fax |
|
| Email |
dns.singh7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anandana |
| Designation |
M.D. Scholar |
| Affiliation |
Government Ayurveda PG College and Hospital Chaukaghat ,Varanasi , Uttar Pradesh 221002 |
| Address |
Department of Rog Nidan Evum Vikriti Vigyana Government Ayurvedic P G College and Hospital , Chaukaghat ,Varanasi Uttar Pradesh
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
6206825280 |
| Fax |
|
| Email |
anandana1001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic P G College And Hospital,Chaukaghat,Varanasi,Uttar Pradesh,221002, India |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic P G College and Hospital Chaukaghat Varanasi |
| Address |
Department of Rog Nidan Evum Vikriti Vigyana Government P.G. Ayurvedic College and Hospital , Chaukaghat ,Varanasi Uttar Pradesh , 221002 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anandana |
Government Ayurvedic P G College and Hospital Chaukaghat Varanasi |
OPD NO. 10 Of Department of Rog Nidan Evum Vikriti Vigyana And OPD NO. 11 of Department of Kayachikitsa, Government P G Ayurvedic College and Hospital, Chaukaghat, Varanasi, Uttar Pradesh
Varanasi
UTTAR PRADESH |
6206825280
anandana1001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GOVERNMENT PG AYURVEDA COLLEGE AND HOSPITAL VARANASI U.P MAHAYOGI GURU GORAKHNATH AYUSH UNIVERSITY GORAKHPUR U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi Churna, Reference: Bhaishajya Ratnavali(Medorogadhikara Prakarana 39/11), Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu/Lukewarm water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1- participants of both genders aged between 18 to 65 years.
2- Body Mass Index (BMI) ≥ 30 kg/m², indicating overweight or obesity.
3- Patient of Sthaulya presenting features as per Ayurvedic text.
4- Presence of at least one of the Ashtadosha associated with Obesity.
5- Willingness to participate in the study and provide informed consent.
6- Ability to comply with the study protocol and follow-up visits. |
|
| ExclusionCriteria |
| Details |
1- Age below 18 years or above 65 years.
2- BMI less than 30 kg/m².
3- Unwillingness to participate in the study or provide informed consent.
4- History of serious medical conditions (e.g., Cardiovascular disease, Renal failure,
Hypothyroidism, Cushing’s Syndrome, Severe Anaemia, Uncontrolled Diabetes, Cancer and
any other Chronic conditions).
5- Pregnancy or breastfeeding.
5- Use of medication or supplements that may interfere with the study outcomes. (e.g. Steroid
medications, Antidepressants and Contraceptive pills). |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in weight,improvement in ashtadosha symptoms and metabolic parameter changes. |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| changes in digestive symptoms,quality of life,safety and tolerability,appetite regulation and anthropometric measurements. |
45 Days. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/12/2024 |
| Date of Study Completion (India) |
23/03/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Objective:To asses the effectiveness of Vidangadi Churna in treating Sthaulya with special reference to ashtadosha.Participants:60 Adults diagnosed with Sthaulya meeting inclusion and exclusion criteria from OPD.
and IPD of department of Rog nidan Evum Vikriti Vigyana and Department of Kayachikitsa of Government PG Ayurvedic Medical College and Hospital Chaukaghat Varanasi.
Interventions: Vidangadi Churna: Administered according to a standardized protocol.
Primary outcome:Reduction in weight, improvement in Ashtadosha symptoms, and metabolic parameter changes.
Secondary outcome:Changes in digestive symptoms, quality of life, safety and tolerability, appetite regulation, and anthropometric measurements.
Follow up -15 Days Dose- 1gram BD with Madhu
Time Period: 1 month
Data Analysis :Data will be analyzed using appropriate statistical methods to compare the effectiveness of the interventions on the primary and secondary outcomes.
Ethical Considerations: The study will be conducted in accordance with ethical guidelines and with informed consent from participants. |