| CTRI Number |
CTRI/2024/10/075867 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Takrarishta Yukta Mustadi Kwatha Basti In the Management of Obesity. |
|
Scientific Title of Study
|
Evaluation of Takrarishta yukta Mustadi Kwatha Madhutailika Basti in the management of Sthaulya (Obesity): A single-arm clinical study. |
| 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 Kinjal Pannalal Bochiya |
| Designation |
PG Scholar |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
7621970219 |
| Fax |
|
| Email |
kinjalbochiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gayatri Gandhe |
| Designation |
HOD and Professor |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9422062452 |
| Fax |
|
| Email |
gayatri.gandhe@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayatri Gandhe |
| Designation |
HOD and Professor |
| Affiliation |
G. J. Patel Institute of Ayurvedic Studies and Research |
| Address |
Department of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital And Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9422062452 |
| Fax |
|
| Email |
gayatri.gandhe@cvmu.edu.in |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
|
|
Primary Sponsor
|
| Name |
Dr Kinjal Pannalal Bochiya |
| Address |
Department of Panchakarma, OPD No. 15, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
| Type of Sponsor |
Other [Self] |
|
|
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 Kinjal Pannalal Bochiya |
S. G. Patel Ayurveda Hospital And Maternity Home |
Department of Panchakarma, OPD No. 15
Anand
GUJARAT |
7621970219
kinjalbochiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G.J.Patel Institute of Ayurvedic Studies and Research S.G.Patel Ayurveda Hospital & Maternity Home INSTITUTIONAL(HUMAN) ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: ATISTHAULYAMÂ (KEVALA-KAPHA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak Samhita Siddhisthana , Procedure details: (Procedure Reference: , Procedure details: (Procedure Reference: Charak Samhita Siddhisthana, Procedure details: ANUVASAN BASTI: Giving Basti position to participant (left lateral position, keeping left leg straight & flexing right leg on abdomen). Smearing anal orifice with Murchhit Tila Taila. Inserting catheter gently in the direction of vertebral canal. Slowly & uniformly pushing Murchhit Tila Taila in the rectum till some oil remains in the syringe. Gentle removal of catheter from anal canal. Tapping on the buttocks. NIRUHA BASTI: Giving Basti position to participant (left lateral position, keeping left leg straight & flexing right leg on abdomen). Smearing anal orifice with Murchhit Tila Taila. Inserting catheter gently in the direction of vertebral canal. Slowly & uniformly pushing contents of the enema can into the Pakvashaya till some mixture remains in the enema can. Gentle removal of catheter from anal canal. Tapping on the buttocks. ) Total Treatment Duration Eight Days First Day And Eighth Day Anuvasana Basti Will Be Given And From Second to Seventh Day Niruha Basti Will Be Given))
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age: 18 to 60 yrs
2 Participants with clinical signs and symptoms of Sthaulya irrespective of gender, caste & religion, who are willing to give consent and get enrolled for the study.
3 B.M.I criteria from 30 kg/m2 to 35 kg/m2 |
|
| ExclusionCriteria |
| Details |
1 Participants below 18 years of age and above 60 years of age
2 Pregnant and lactating women
3 Participant with uncontrolled hypertension, diabetes, and other comorbidity
4 Participant diagnosed HIV and HbsAg
5 Participant on hormonal therapies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Hemogram
2.ESR
3.Lipid Profile
4.LFT |
1st Day And 30th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Shrama Shwasa/Kshudra Shwasa(Dyspnea)
2.Atikshudha (Excessive appetite)
3. Ati-Jarana Shakti (enhanced digestion)
4.Atipipasa (Excess Thirst)
5.Atinidra (Excess Sleep)
6.Atisweda (Excessive Sweating)
7.Sweda Durgandhi(Foul Smell)
8.Alasya (Laziness)
9.Angagaurava (Heaviness of Body)
10.Alpa Vyavaya(Loss of Sexual Activity)
11.BMI
12.Skin fold test Vernier calipers (lt, rt,
front)
13.Circumference Ratio (cm) - (waist to
hip) |
1st Day, 8th Day,15th Day, 21st Day, 30th Day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| Date of Study Completion (India) |
13/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Obesity is a mild state of chronic inflammation of adipose tissue and a state of malnutrition by excess, which leads to a defective hormonal and immune system. “Ashtau Ninditiya†chapter described in the beginning of Yojana Chatushka of Charak Samhita states about types of bodies which are deficient in the context of health. Atisthula is one such condition which can be corelated with obesity in modern science.A study published in Lancet rates India to be among top three most obese nations stating 70% population overweight. The Lancet study also revealed that 30 million adults in India are either overweight or obese, and 62 million diabetic Indians exhibit obesity-related characteristics such as excess body fat, abdominal adiposity, and fat deposition in ectopic sites. Medicines, diet regulation, exercises, stress management, bariatric surgeries are the current trends followed to reduce obesity. Even though several approaches are stated to benefit, the spectrum of problem is growing. Hence yet, a satisfactory solution is awaited. in the study one such solutation is being carried upon, to solve the current problem. in the study subjects will be selected according to Inclusion and Exclusion Criteria as mentioned, then after taking the concent subjects will be treated with Takrarishta Yukta Mustadi Kwatha Madhutailika Basti for eight days consisting 2 anuvasan(first and eighth) and 6 niruh(second to seventh). Further follow up will be taken on 8th,15th,21st, 30th day according to the subjective and objective criteria. This study will be useful in stating a definitive treatment for obesity in the present era using Takrarishta Yukta Mustadi Kwatha Madhutailika Basti. |