| CTRI Number |
CTRI/2025/03/083660 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Triphaladi Enema in Obesity |
|
Scientific Title of Study
|
A single arm clinical study to evaluate effect of Triphaladi Basti in the management of Sthaulya |
| 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 Samiksha Diliprao Puranik |
| Designation |
M. D. Scholar Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurveda Mahavidyalaya, OPD No. 6, Department of Panchakarma, Sane Guruji Arogya Kendra, Hadapsar, Malwadi, Pune, 411028 Maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
9834725575 |
| Fax |
|
| Email |
puraniksamiksha12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maya Gokhale |
| Designation |
Head of Department of Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurveda Mahavidyalaya, OPD No. 6, Department of Panchakarma, Sane Guruji Arogya Kendra, Hadapsar, Malwadi, Pune, 411028 Maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
9422323285 |
| Fax |
|
| Email |
drmayagokhale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Samiksha Diliprao Puranik |
| Designation |
M. D. Scholar Panchakarma |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya |
| Address |
Sumatibhai Shah Ayurveda Mahavidyalaya, OPD No. 6, Department of Panchakarma, Sane Guruji Arogya Kendra, Hadapsar, Malwadi, Pune, 411028 Maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
9834725575 |
| Fax |
|
| Email |
puraniksamiksha12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Samiksha Diliparo Puranik |
| Address |
Sane Guruji Arogya Kendra, Malwadi, Hadapsar, Pune 411028, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Samiksha Diliprao Puranik |
Sane Guruji Arogya Kendra |
OPD No 6, Department of Panchakarma, Malwadi, Hadapsar, Pune 411028
Pune
MAHARASHTRA |
9834725575
puraniksamiksha12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.A.M.s SSAM and Sane Guruji Arogya Kendra Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | AsthApana-bastiH/ nirUha-bastiH, आस्थापन-बस्तिः/ निरूह-बस्तिः | (Procedure Reference: Samhita, Procedure details: Procedure Reference: Samhita, Procedure details: A course of 15 basti in which on 1st, 7th & 15th day matra basti of til tail 60ml & for rest of the days Niruha Basti of Triphaladi Kwath of 480ml will be given. One Basti will be given per day. Route of administration will be per-rectum. )
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Sthaulya.
Patients with BMI between 25 to 40.
Age Group - 18 to 60 years.
Gender - Male & Female |
|
| ExclusionCriteria |
| Details |
Patient suffering from systemic disease which may cause interference in the course of treatment.
Pregnancy and lactation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Triphaladi Basti in Sthaulya given for 15 days. |
To study the effect of Triphaladi Basti in Sthaulya given for 15 days.
Assessment of BMI is on 0th, 7th, 15th and 30th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Triphaladi Basti on lipid profile given for 15 days. |
Assessment of lipid profile, waist to hip ratio and anthropometry on 0, 15th day and daily follow up for Basti Dharan Kaal.
Assessment of subjective criteria on 0th, 7th, 15th and 30th day. |
|
|
Target Sample Size
|
Total Sample Size="51"
Sample Size from India="51"
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)
|
07/04/2025 |
| 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="6"
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
|
This is a single arm study of Niruha Basti of Triphaladi Kwath. The primary objective is to study the effect of Triphaladi Basti in Sthaulya given for 15 days. The secondary objective is to study effect of Triphaladi Basti on Lipid Profile. Observation will be drawn from the outcome of treatment. |