| CTRI Number |
CTRI/2025/04/084358 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to test the effect of Shadushan Guggulu and Triphala Kwath in the management of Dyslipidemia. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Shadushan Guggulu and Triphala kwath in the management of Medoroga w.s.r. to 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 |
Prof Dr Sunil Thakur |
| Designation |
Professor |
| Affiliation |
Rajiv Gandhi Govt.Post Graduate Ayurvedic college and Hospital Paprola(HP) |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra(HP)176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anjana Mishra |
| Designation |
Head Of Department |
| Affiliation |
Rajiv Gandhi Govt.Post Graduate Ayurvedic college and Hospital Paprola(HP) |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra(HP)176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418312324 |
| Fax |
|
| Email |
dranjana269@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shri Devi |
| Designation |
MD Scholar |
| Affiliation |
Rajiv Gandhi Govt.Post Graduate Ayurvedic college and Hospital Paprola(HP) |
| Address |
Rajiv Gandhi Govt.Post Graduate Ayurvedic college and Hospital Paprola(HP)176115
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9805871807 |
| Fax |
|
| Email |
shrinegiee@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prof Dr Vijay Chaudhary |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Kangra(HP)176115 |
| Type of Sponsor |
Government 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 |
| ProfDrSunil Thakur |
Rajiv Gandhi Govt.Post Graduate Ayurvedic college and Hospital Paprola(HP) |
Room no -317 Hospital Building Rajiv Gandhi Govt.Post Graduate Ayurvedic college and Hospital Paprola(HP)
Kangra
HIMACHAL PRADESH |
09816195001
dr.skumarthakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala kwatha, Reference: Sharangdhar madhyam khand 2/116, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shadushan Guggulu, Reference: Yogratnakar, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Serum lipid profile :
Serum Cholesterol - 200 to 350 mg/dl
Serum Triglycerides - 150 to 350 mg/dl
Serum LDL - 100 to 200 mg/dl
Serum VLDL - 30 to 100 mg/dl
Serum HDL - 20 to 40 mg/dl
Patients willing to participate in the trial.
Patients between the age group of 30-70 years of either gender will be selected for the study. |
|
| ExclusionCriteria |
| Details |
Patient having major illness like Type-II Diabetes mellitus, Carcinoma, advanced Renal and Liver disorders.
Pregnant females and lactating mother.
Patients who has completed participation in any other clinical trial during the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To reduce the level of S.Cholesterol level below 200mg/dl
S.Triglycerides level below 150mg/dl
S.LDL level below 100mg/dl
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical safety of Shadushan Guggulu and Triphala Kwath in patients of Medoroga w.s.r. to Dyslipidaemia. |
3 months |
|
|
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 4 |
|
Date of First Enrollment (India)
|
20/06/2025 |
| 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="0"
Months="3"
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
|
At the end of the trial, collected data will be analyzed by using appropriate statistical methods and will be present in the form of thesis. |