| CTRI Number |
CTRI/2024/06/069222 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Comparative study to evaluate the effect of Shuddha guggulu with and without virechan karma ( purgation therapy ) in patients of dyslipidimia. |
|
Scientific Title of Study
|
Comparative clinical trial to evaluate the efficacy of shuddha guggulu with and without virechana karma in 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 |
Dr Manoj Shamkuwar |
| Designation |
Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9354925019 |
| Fax |
|
| Email |
manojshamkuwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Shamkuwar |
| Designation |
Head of Department |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi
DELHI
110005
India |
| Phone |
9354925019 |
| Fax |
|
| Email |
manojshamkuwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniket Rajput |
| Designation |
MD Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, PG room, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
8587986027 |
| Fax |
|
| Email |
aniketrajput9650182346@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd,
Block 56, Karol Bagh, New Delhi, Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and unani tibbia college and hospital |
| Address |
Department of panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Rd, Block 56, Karol Bagh, New Delhi, central delhi |
| 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 |
| Dr Aniket Rajput |
Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi |
Department of
Panchakarma,
Ayurvedic and Unani
Tibbia College and
Hospital, Ajmal Khan
Rd, Block 56, Karol
Bagh, New Delhi, Delhi
110005
Central
DELHI |
8587986027
aniketrajput9650182346@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and unani tibbia college and hospital |
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 | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak samhita, sutra sthan, chapter 23 , shloka no. 8, Procedure details: pachan ( 3-7 days ) followed by snehapan ( 3-7 days ) , followed by abhyanga swedana for 3 days followed by virechana karma with trivrit avleha (30-60gm) and phaltrikadi kwath ( 100-200 ml ))
(1) Medicine Name: Shuddha guggulu, Reference: Anonymus, Ayurvedic pharmacopeia of India, Part 1, Vol 1, Delhi; Govt of India ; p- 73, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 38 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shuddha guggulu , Reference: Anonymus, Ayurvedic pharmacopeia of India, Part 1, Vol 1, Delhi; Govt of India ; p- 73, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Any one of the dearranged parameter of lipid profile ( Total cholesterol, Triglyceride, LDL,
HDL, VLDL)
2) Patient of either sex of age between 20 – 65.
|
|
| ExclusionCriteria |
| Details |
1) Patients who are contraindicated for virechana karma- like lower GI bleeding, Prolapse of rectum, incontinence of stool, Pregnant and lactating women will not be included in the trial in group A.
2) CAD patients , patients on any ongoing medications that are likely to affect lipid levels.
3) Patients with renal or hepatic impairement (Sr creatinine greater than 1.8mg/dl, SGPOT greater than 200u/L, SGPT greater than 280uL).
4) Patients with co-morbid conditions such as Hypertension grade 2 ( greater than or equal to 160/100mm of Hg) or more, Diabetes Mellitus (having HbA1c greater than 7.5 percent with or without hyperglycemic medications
5) Patients who are on anti tubercular , anti retroviral and anti hyperlipidemic medications.
6) Patients requiring emergency treatment
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes would be measured by lab investigation of extended lipid profile (
including total cholesterol, triglyceride, ldl, vldl, hdl, apolipoprotein A1 and
apolipoprotein B)
|
Primary outcomes would be measured by lab investigation of extended lipid profile (
including total cholesterol, triglyceride, ldl, vldl, hdl, apolipoprotein A1 and
apolipoprotein B)
On baseline
60 days ,i.e, after completion of trial
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To asses the add on effect of virechana karma with Shuddha guggulu on Hs-CRP level.
The proportion of patients showing improvement in the quality of life using the
questionnaire of WHO-QOL Bref Scale.
|
After 60 days ie. post completion of the intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/06/2024 |
| Date of Study Completion (India) |
22/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/11/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Cholesterol levels are estimated to cause 18% of the global CVDs and 56% of global ischemic heart disease (IHD). For every 1% reduction in lipid level , the risk of heart disease reduces by 2.5%. Dyslipidemia is a established risk factor for atherosclerotic disease. In india , there has been an alarming increase in the prevalence of CVD over the past two decades. In this view it is need of the hour to find a cost effective , non invasive treatment protocol to combat Dyslipidemia that May act as a preventive tactic for cardiovascular diseases. This study is an attempt to explore the efficacy and add on effect of virechana karma in dyslipidemic patients by normalizing lipid metabolism. |