| CTRI Number |
CTRI/2025/08/093129 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effects of krumighnadi Kashaya in obesity |
|
Scientific Title of Study
|
A Randomized Controlled Trial to evaluate the efficacy of Krumighnadi Kashayaya and Varadi Kashayaya in management of Sthaulya with Special referance 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 |
Dr Kiran Chandrakant Waghmode |
| Designation |
M.D.(Kayachikitsa) Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8888315364 |
| Fax |
|
| Email |
Kiranwaghmode1k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachinkumar Patil |
| Designation |
Head of Department ,Department of Kayachikitsa |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9822603608 |
| Fax |
|
| Email |
drsachinkumarpatil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Chandrakant Waghmode |
| Designation |
M.D.(Kayachikitsa) Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune |
| Address |
O.P.D NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
8888315364 |
| Fax |
|
| Email |
Kiranwaghmode1k@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMS Sumatibhai Shah Ayurved College O.P.D NO 2 Kayachikitsa Department Ground Floor Sane guruji Arogya Kendra Hadapsar Pune-411028 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Kiran Chandrakant Waghmode |
| Address |
O.P.D NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
O.P.D NO 2 Kayachikitsa Department Ground Floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune |
| 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 Kiran Chandrakant Waghmode |
Sane guruji Arogya Kendra Malwadi Hadapsar Pune 411028 |
O.P.D NO 2 Kayachikitsa Department ground floor Sane Guruji Arogya Kendra Malwadi Hadapsar Pune
Pune
MAHARASHTRA |
08888315364
kiranwaghmode1k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee MAMS Sumatibhai Shah Ayurved Mahavidyalaya and Sane guruji Arogya Kendra |
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 | Drug | Classical | | (1) Medicine Name: Krumighnadi Kshaya, Reference: Sahastrayog, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Varadi Kshaya, Reference: Sahastrayog, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients from age group of 20 to 60 years irrespective of gender, religion, socioeconomic status,
marital status.
2. Patients of Sathualya i.e. as per signs and symptoms BMI more than 25 to 35
including overweight Obese Class I as per signs and symptoms mentioned in
Ayurvedic texts
3 BMI more than 25
4 Patients fulfilling classical lakshanas of Sthaulya |
|
| ExclusionCriteria |
| Details |
1. Pregnant women, lactating mother.
2. Acute life threatening conditions like C.V.A, Acute M.I.
3. B.M.I. more than 35
4. Known Cases of sever endocrine disorders
5. Patients having major illness like IDDM which is poorely control |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lipid Profile
To compare the efficacy of Krumighnadi Kashaya and Varadi Kshaya |
At baseline,15th day,30th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Lipid Profile
To study adverse effect of Krumighnadi Kashaya and Varadi Kashaya |
At baseline,15th day,30th day |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 3 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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
|
In todays era , only modern medicine is not so effective for Obesity So with the help of Ayurvedic Medicine and lifestyle changes one can get the desired effect in the obesity treatment. Now a days obesity is leading lifestyle disorder. One may face many problems when he/she suffers from obesity. Modern treatment has many limitations to control obesity but the Ayurvedic Medicine and lifestyle modification does a desired effect in the control of obesity. The rationale for conducting Randomized Controlled Trial clinical study to evaluate the efficacy of Krumighnadi Kashaya in Sthaulya (obesity) lies in the need for evidence-based medicine. It aims to provide scientific validation for the traditional use of Varadi Kashaya in managing obesity, potentially offering alternative or complementary treatments to conventional therapies. Such studies can contribute to the integration of traditional medicine into mainstream healthcare, benefiting patients by expanding treatment options and improving overall healthcare outcomes.
|