| CTRI Number |
CTRI/2025/12/098982 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To Study The Effect Of Krimighanadi Kashaya In Obesity |
|
Scientific Title of Study
|
A Randomized Clinical Study On Krimighanadi Kashaya 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 |
Dr Apurva Gupta |
| Designation |
M.D. Scholar |
| Affiliation |
Jammu Institute Of Ayurveda And Research |
| Address |
P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9149403433 |
| Fax |
|
| Email |
apurvagupta6690@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Mahajan |
| Designation |
Professor |
| Affiliation |
Jammu Institute Of Ayurveda And Research |
| Address |
P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9419119123 |
| Fax |
|
| Email |
Dr.nitinmahajan1608@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apurva Gupta |
| Designation |
M.D. Scholar |
| Affiliation |
Jammu Institute Of Ayurveda And Research |
| Address |
P.G. Department Of Kayachikitsa Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir
Jammu
JAMMU & KASHMIR
181123
India |
| Phone |
9149403433 |
| Fax |
|
| Email |
apurvagupta6690@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jammu Institute Of Ayurveda And Research, Nardni, Jammu, Jammu And Kashmir, 181123, INDIA |
|
|
Primary Sponsor
|
| Name |
Jammu Institute Of Ayurveda And Research |
| Address |
Jammu Institute Of Ayurveda And Research, Nardani Bajwan, Bantalab Jammu Jammu And Kashmir 181123 |
| 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 Apurva Gupta |
Jammu Institute Of Ayurveda And Research |
P.G. Department Of Kayachikitsa, OPD and IPD of hospital Jammu Institute Of Ayurveda And Research, Nardni Bajwan, Bantalab Jammu,Jammu And Kashmir 181123
Jammu
JAMMU & KASHMIR |
9149403433
apurvagupta6690@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jammu Institute of Ayurveda & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krimighanadi Kashaya, Reference: Central Council for Research in Ayurvedic Sciences. Sahasrayogam. New Delhi, CCRAS -1990, Reprint : 2011, PaGE NO.21 (1, 2, 4), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Follow up :-
on 15th day, 30th day and 45th day
-Drug free Follow up :-
on 45th day
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either sex of age between 18years to 60 years.
2.Patients having signs and symptoms of Obesity like large body frame having extra fat around the waist, difficulty in doing daily activities, lethargy, breathlessness increased weight, snoring, having sweating difficulty while sleeping.
3.Patients having classical signs and symptoms of Sthoulya like Chal Udara Stana Sphika, Javoparodha, Kruchvyavaya, Dourbalyta , Atikshudha, Atitrishna etc.
4.Patients with BMI between 25kg/m2 to 39 kg/m2
5.Patients willing to participate and able to provide signed informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients age less than 18 and more than 60 years.
2.Pathophysiology or Genetic Syndromes associated with Sthoulya.
3.Malignancy, poorly controlled diabetes mellitus, hypertension.
4.Patients suffering from pulmonary diseases, cardiac diseases will not be taken from study.
5.Alcoholic and drug abusers, pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Subjective and objective Parameters of Sthoulya
Subjective:. Dourgandya
Ang Gourava,Utsaha Hani,Kshudra Swasa,Ati Pipasa, Chala Spikha Udara Stana,Dourbalya,Nidraadhikya,Swedadhikya Snigdhangata,Alpa Vyavaya
Objective:Body Mass Index |
Assessment: Percentage relief in symptoms and signs after 30 days of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in Quality-of-Life Indicators
2.Improvement in Functional Capacity
3.Overall Therapeutic Response Assessment |
Assessment after drug free period |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/05/2026 |
| 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 clinical study aims to evaluate the efficacy of Krimighanadi Kashaya in the management of Sthoulya (Obesity), a condition described in Ayurveda as Medo-dhatu vriddhi associated with Kapha-Vata imbalance and classified under Ashtau Nindita. With the global rise of obesity and its related metabolic complications, there is a growing need for safe, sustainable, and holistic treatment approaches. Ayurveda offers a comprehensive management strategy through Nidana-parivarjana, Ahara-Vihara regulation, and Medohara therapies. Krimighanadi Kashaya, a classical formulation containing Vidanga, Triphala, Ajmoda, Katuki, Trikatu, Guggulu, and Amrita, is traditionally indicated for Kapha-Medo disorders due to its Deepana-Pachana, Lekhana, Agnivardhaka and Medohara actions. This single-arm, open-label, randomized pre-post clinical trial will include 30 participants aged 18–60 years with BMI 25–39.9 kg/m². The intervention will be administered for 30 days with follow-ups on days 15, 30, and 45, assessing both Ayurvedic and biomedical parameters such as subjective symptoms of Sthoulya and BMI. The study intends to generate evidence on the therapeutic potential, safety, and overall effectiveness of Krimighanadi Kashaya in improving obesity-related clinical outcomes and restoring metabolic balance. |