| CTRI Number |
CTRI/2025/09/094975 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate the effect of Ayurvedic drug Lekhaniya Mahakashya and Mustadighan vati in Sthaulya(obesity) |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Lekhaniya Mahakashya and Mustadighan vati in Sthaulya(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 |
Dr Himani Bhardwaj |
| Designation |
MD Scholar, Department of Kayachikitsa |
| Affiliation |
Uttrakhand Ayurveda University, Gurukul Campus, Hardwar |
| Address |
OPD 5 Department of Kayachikitsa, Uttrakhand Ayurveda University, Gurukul Campus
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9528529607 |
| Fax |
|
| Email |
bhimani0995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punita Pandey |
| Designation |
Professor |
| Affiliation |
Uttrakhand Ayurveda University, Gurukul Campus, Hardwar |
| Address |
OPD 5 Department of Kayachikitsa, Uttrakhand Ayurveda University, Gurukul Campus
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9319394485 |
| Fax |
|
| Email |
pandey.punita62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Punita Pandey |
| Designation |
Professor |
| Affiliation |
Uttrakhand Ayurveda University, Gurukul Campus, Hardwar |
| Address |
OPD 5 Department of Kayachikitsa, Uttrakhand Ayurveda University, Gurukul Campus
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9319394485 |
| Fax |
|
| Email |
pandey.punita62@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttrakhand Ayurveda University, Gurukul Campus, Hardwar 249404 |
|
|
Primary Sponsor
|
| Name |
Dr Himani Bhardwaj |
| Address |
PG Department of Kayachikitsa, Uttrakhand Ayurveda University, Gurukul Campus, Hardwar, UTTRANCHAL 249404 |
| 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 Himani Bhardwaj |
Uttrakhand Ayurveda University, Gurukul Campus, Hardwar |
OPD 5 Department of Kayachikitsa, Uttrakhand Ayurveda University, Gurukul Campus
Hardwar
UTTARANCHAL |
09528529607
bhimani0995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee UAU Gurukul Campus,Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mustadi Ghanvati, Reference: ch.su.23/13, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -koshana jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lekhaniya Mahakashya, Reference: ch.su.4/8, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Individuals of either gender between the age group of 20-60 years will be selected
2)Individuals having classical sign and symptoms of Sthaulya(obesity)
3)Individuals between BMI of 25-34.9 will be selected |
|
| ExclusionCriteria |
| Details |
1)K/C/O uncontrolled diabetes, hypothyroidism, hypertension
2)Long term steroid treatment
3)Pregnant and lactating women
4)Individuals having age of less than 18 and more than 60 years
5)cases of alcohol dependence and drug abuse
6)Individuals having BMI more than 34.9
7)obesity due to genetic causes |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relef in following parameters:
1)Swas kasta(breathlessness)
2)Janusandhishoola(pain in both knee joints)
3)Atinidrata(excessive sleep)
4)Kshudaatimatram(increased hunger)
5)Pipasaatiyogam(excessive thirst)
6)Swedadhikiya(excessive sweating)
7)Durgandhyam(foul smell from body)
8)Daurbalya(weakness) |
Assessment of Subjective Parameters at 1st day, 30th day, 60th day, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief in following parameters
1)Body weight
2)BMI- between 25 to 34.9kg/m2
3)Anthropometry Measurements
a)Skin Fold Thickness measured with digital Vernier Caliper at biceps, triceps, supra-iliac and subscapular region
b)Waist Circumference(more than 90cm in man and 80cm in female)
c)Waist hip ratio(more than 0.88 in male and 0.80 in female) |
Assessment of Subjective Parameters at 1st day and 90th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
30/09/2025 |
| 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 an open-label, double-arm comparative clinical trial to evaluate the efficacy of Lekhaniya Mahakashya and Mustadi Ghanvati in the management oF Sthaulya(obesity). A total of 40 patients will be randomly divided into two groups of 20 each. One group will recieve Lekhaniya Mahakashya kwath and the other group will recieve Mustadi Ghanvati for 90 days. Assessment will be done on the basis of subjective and objective parameter. The aim is to compare both drugs and provide safe and efficient ayurvedic intervention of sthaulya.
|