| CTRI Number |
CTRI/2025/10/095853 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to evaluate effect of Gomutra Haritaki and Navak Guggulu in Medoroga (Dyslipidemia) |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY OF GOMUTRA HARITAKI AND NAVAK GUGGULU IN MEDOROGA (DYSLIPIDEMIA) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamta |
| Designation |
Pg scholar |
| Affiliation |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan Haridwar Uttarakhand |
| Address |
OPD NO 13 DEPARTMENT OF KAYACHIKITSA PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN PATANJALI YOGPEETH, HARIDWAR UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7015712025 |
| Fax |
|
| Email |
dalalmamta112@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Girish KJ |
| Designation |
MD ,PhD |
| Affiliation |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan Haridwar Uttarakhand |
| Address |
OPD N0 13 DEPARTMENT OF KAYACHIKITSA PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN PATANJALI YOGPEET HARIDWAR UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Girish KJ |
| Designation |
Professor and Head |
| Affiliation |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan Haridwar Uttarakhand |
| Address |
OPD No 13 DEPARTMENT OF KAYACHIKITSA PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN PATANJALI YOGPEETH HARIDWAR UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9448646855 |
| Fax |
|
| Email |
girideepa@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya ayurvigyan evam anusandhan sansthan Haridwar Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurved college opd no.13,14 |
| Address |
Patanjali Bhartiya ayurvigyan evam anusandhan sansthan Haridwar Uttarakhand |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Mamta |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Department of Kayachikitsa, OPD no. 13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, 249405, Uttarakhand
Hardwar
UTTARANCHAL |
7015712025
dalalmamta112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gomutra Haritaki, Reference: Ashtang Hriday Chikitsa sthan 8/55, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Triphala kwath), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Navak Guggul, Reference: Bhesajya Ratnawali 39/42, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Triphala kwath), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with Medoroga (Dyslipidemia) based on lipid profile criteria
Age 20 to 70 years of either gender
Patients with BMI mpre than 25 kg per m²
Patients willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with past history of myocardial infarction (MI), unstable angina, or stroke
Patients with AIDS, cancer, tuberculosis, uncontrolled diabetes mellitus, psychiatric illness, or uncontrolled hypertension
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Lipid Profile Parameters ( Total Cholesterol, LDL,HDL,Triglyceride, VLDL) |
Baseline,30 days and 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms such as breathlessness, excessive thirst, excessive hunger, excessive sweating, and lethargy |
Baseline,30 days and 60 days |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Comparative Clinical Study of Gomutra Haritaki and Navak Guggulu in Medoroga (Dyslipidemia) Scholar: Mamta Institution: Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, under Uttarakhand Ayurved University Department: Kayachikitsa Study Period: 18 months Sample Size: 60 patients Summary: This clinical study investigates the comparative efficacy of two Ayurvedic formulations—Gomutra Haritaki and Navak Guggulu—in the management of Medoroga, which is correlated with dyslipidemia in modern medicine. Medoroga, as described in Ayurveda, results from sedentary lifestyle and improper dietary habits leading to the accumulation of Meda (fat), and manifests with symptoms like heaviness, breathlessness, excessive thirst, and lethargy.
Due to the side effects and limitations of modern hypolipidemic drugs, the study explores the potential of Ayurvedic alternatives that are cost-effective, safe, and holistic. Gomutra Haritaki is known for its Amapachana and Agnideepana effects, whereas Navak Guggulu has Lekhana, Medohara, and Srotoshodhana properties.
A randomized, open-label, two-arm clinical trial is planned, with 30 patients in each group. Patients will be treated for 60 days and assessed using both modern (lipid profile, BMI, body weight) and Ayurvedic parameters (subjective symptoms of Medoroga). Results will be statistically analyzed to evaluate and compare the efficacy of both drugs. |