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CTRI Number  CTRI/2025/09/095438 [Registered on: 29/09/2025] Trial Registered Prospectively
Last Modified On: 26/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Evaluation of modified Ayurvedic Basti Procedure with Vachadi Gana for obesity 
Scientific Title of Study   A Randomised control trial to evaluate the effect of modified kala basti krama with vachadi gana in sthoulya with special reference to obesity. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vrushali Ramesh Gavit 
Designation  PG Scholar 
Affiliation  Institute 
Address  R.A. PODAR AYU MEDICAL COLLEGE WORLI, MUMBAI

Mumbai
MAHARASHTRA
400018
India 
Phone  9405362931  
Fax    
Email  vrushaligavit498@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sheetal Lodha 
Designation  Associate Proffessor 
Affiliation   
Address  Opd no 7 , Panchakarma dept , m. a.podar hospital worli

Mumbai
MAHARASHTRA
400018
India 
Phone  9920792037  
Fax    
Email  vd.sheetal4u@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Sheetal Lodha 
Designation  Associate Proffessor 
Affiliation   
Address  R.A. PODAR AYU MEDICAL COLLEGE WORLI, MUMBAI

Mumbai
MAHARASHTRA
400018
India 
Phone  9920792037  
Fax    
Email  vd.sheetal4u@rediffmail.com  
 
Source of Monetary or Material Support  
Opd No.7 , Panchakarma Department , M.A. Podar ayu Hospital , Worli , Mumbai . pincode -400018 
 
Primary Sponsor  
Name  R. A. Podar Govt (Ayu) College, Worli , Mumbai pincode-400018 , country - India 
Address  R. A. Podar Govt (Ayu) College, Worli, Mumbai . Dr Annie Besant road pincode -400018 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vrushali Gavit  M. A. Podar Ayu hospital worli, mumbai  opd no 7 , panchakarma , M. A. podar hospital worli , mumbai
Mumbai
MAHARASHTRA 		 9405362931

vrushaligavit498@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS Committee of institution, R A Podar Govt Ayu College, Worli  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak sidhi 3/69, Procedure details: Patient was adviced to take light meal on previous night . Adviced to evacuate bladder and bowel. Niruha Basti is given in empty stomach. Anuvasan basti is given after taking food . Patient was given left lateral position with left leg extended and right leg flexed and was advised to keep his/her hand below the head .lubricate the tip of cathetor with oil .slowly insert the cathetor into the anus slowly release the clip and allow the basti medicine to flow into rectum . carefully remove the cathetor ))
(1) Medicine Name: vachadi gana anuvasan basti, Reference: Ashtang hruday sutra 15/35-36, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 4 Days
(2) Medicine Name: vachadi gana niruha basti, Reference: Ashtang hruday sutra 15/35-36, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 750(ml), Frequency: od, Duration: 12 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak sidhi 1/ 48, Procedure details: Patient was adviced to take light meal on previous night . Adviced to evacuate bladder and bowel. Niruha Basti is given in empty stomach. Anuvasan basti is given after taking food . Patient was given left lateral position with left leg extended and right leg flexed and was advised to keep his/her hand below the head .lubricate the tip of cathetor with oil .slowly insert the cathetor into the anus slowly release the clip and allow the basti medicine to flow into rectum . carefully remove the cathetor ))
(1) Medicine Name: vachadi gana niruha basti, Reference: Ashtang hruday 15/35-36, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 750(ml), Frequency: od, Duration: 6 Days
(2) Medicine Name: vachadi gana anuvasan basti, Reference: Ashtang hruday 15/35-36, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 10 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  I) Patients of any gender, between age 20 to 50 years.
II) BMI between 25 to 34.9 kg/m2 .
III) Patients having signs and symptoms of sthoulya.
IV) Primary obesity (E66.0 of ICD-10 criteria)
IV) patient is fit for basti.
 
 
ExclusionCriteria 
Details  i) patient not fit for Basti karma.
i) Patients diagnosed with carcinoma, tuberculosis, HIV positive or any other life threatening condition.
ii)Patients having any ano-rectal diseases like fistula, fissure-in-ano, hemmorhoids.
iii) Pregnant and lactating women.
iv) Drug induced obesity like steroids and antipsychotic drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
62  4 to 5 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of BMI , waist hip ratio, abdominal girth  4 to 5 weeks 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   20/10/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
A Randomised Control Trial to Evaluate the Effect of Modified Kala Basti Krama with Vachadi Gana in Sthoulya with Special Reference to Obesity”
Study Type:
Comparative study
Randomised Control Trial (RCT) – Parallel arm experimental design
Two groups:
Control Group: Standard Kala Basti Krama
Experimental Group: Modified Kala Basti Krama (3 consecutive Niruha followed by 1 Anuvasana)
Objective:
To evaluate the efficacy of modified Kala Basti krama using Vachadi Gana drugs in managing Sthoulya (obesity).
Assess both objective parameters (BMI, abdominal girth, waist-hip ratio) and subjective symptoms (like Chalasphik, Alasya, Atinidra, etc.)
 Design Details:
Randomised, Controlled, Parallel-arm clinical trial
Duration: 32 days
Sample size: 31 patients
Inclusion: Age 20–50, BMI 25–34.9, fit for Basti
Exclusion: Pregnancy, severe illness, anorectal diseases
Treatment Details:
Vachadi Gana Kashaya used for Niruha Basti
Vachadi Gana Taila used for Anuvasana Basti
Total 16 Basti over 16 days (standard vs modified order)
Outcomes:
Change in BMI, waist-hip ratio, abdominal girth
Reduction in symptoms related to Kapha-Meda dushti
Safety and tolerability of modified basti schedule
Conclusion (Expected):
To determine whether modified Kala Basti Krama is more effective than traditional Kala Basti for managing Sthoulya, with fewer side effects and better results.





 
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