| CTRI Number |
CTRI/2025/09/094539 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vachadi Gana and Haridradi Gana Kala Basti in Dyslipidemia |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Vachadi Gana and Haridradi Gana Kala Basti 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 |
Kritika Verma |
| Designation |
Pg Scholar |
| Affiliation |
Himalayiya Ayurvedic Pg Medical College And Hospital |
| Address |
Opd No 11 Department Of Panchakarma Himalayiya Ayurvedic Pg Medical College And Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun
Dehradun UTTARANCHAL 248140 India |
| Phone |
9878419120 |
| Fax |
|
| Email |
kritikamailbox@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shrimant Gangaram Chavan |
| Designation |
Professor |
| Affiliation |
Himalayiya Ayurvedic Pg Medical College And Hospital |
| Address |
Opd No 11 Department Of Panchakarma Himalayiya Ayurvedic Pg Medical College And Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun
Dehradun UTTARANCHAL 248140 India |
| Phone |
7204863633 |
| Fax |
|
| Email |
drshrimantgc.bc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shrimant Gangaram Chavan |
| Designation |
Professor |
| Affiliation |
Himalayiya Ayurvedic Pg Medical College And Hospital |
| Address |
Opd No 11 Department Of Panchakarma Himalayiya Ayurvedic Pg Medical College And Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun
Dehradun UTTARANCHAL 248140 India |
| Phone |
7204863633 |
| Fax |
|
| Email |
drshrimantgc.bc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Panchakarma Himalayiya Ayurvedic Pg Medical College And Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun 248140 |
|
|
Primary Sponsor
|
| Name |
Dr Kritika Verma |
| Address |
Himalayiya Ayurvedic Pg Medical College And Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun |
| 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 Kritika Verma |
Himalayiya Ayurvedic Pg Medical College And Hospital |
Opd no 11 Department Of Panchakarma Himalayiya Ayurvedic Pg Medical College And Hospital Fatehpur Tanda Majri Grant Via Doiwala Dehradun 248140 Dehradun UTTARANCHAL |
9878419120
kritikamailbox@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Minutes Of Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Jadavji Trikamji Acharya and Narayanaram Acharya editor, Sushruta Samhita 2005 edition, p.73,74, Procedure details: In Group A, initially, for 5 Days, Shunthi Churna with lukewarm water will be given to registered patients for Deepana & Pachana. After assessing the patients agni, Sthanik Abhyanga will be done with Sarshapa Tail, followed by Nadi Swedan with Vachadi Gana siddha Kwatha. After this Kala Basti with Vachadi Gana will be administered for 16 days as mentioned in Ashtanga Hridyam which includes, Anuvasana Basti with Vachadi Gana siddha Tail 120ml and Vachadi Gana Niruha Basti 480ml will be administered.) (1) Medicine Name: Vachadi Gana, Reference: Asthanga Hridyam, Sutra Sthana 15/34,35, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 6 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Jadavji Trikamji Acharya and Narayanaram Acharya editor, Sushruta Samhita 2005 edition, p.73,74, Procedure details: In Group B, initially, for 5 Days, Shunthi Churna with lukewarm water will be given to registered patients for Deepana & Pachana. After assessing the patients agni, Sthanik Abhyanga will be done with Sarshapa Tail, followed by Nadi Swedan with Haridradi Gana siddha Kwatha. After this Kala Basti with Haridradi Gana will be administered for 16 days as mentioned in Ashtanga Hridyam which includes, Anuvasana Basti with Haridradi Gana siddha Tail 120ml and Haridradi Gana Niruha Basti 480ml will be administered.) (1) Medicine Name: Haridradi Gana, Reference: Asthanga Hridyam, Sutra Sthana 15/34,35, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 480(ml), Frequency: od, Duration: 6 Days |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for trial with consent.
Patients who are fit for Basti. |
|
| ExclusionCriteria |
| Details |
Patients having serious ailments like Insulin Dependant Diabetes Mellitus or poorly controlled Diabetes Mellitus, Myocardial Infarction, Cardiac failure, Renal insufficiency, Hypothyroidism, Malignancies, gluco-corticosteroids induced dyslipidaemia.
Patients with Secondary Dyslipidemia.
Patients unfit for Basti.
Patients on statins/any other drug.
Pregnant females and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced Levels of Lipid Profile |
3 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in levels of Total Cholesterol, Triglycerides, LDL & HDL |
8 WEEKS |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
22/09/2025 |
| 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
|
Dyslipidemia, characterized by elevated cholesterol, triglycerides, LDL or reduced HDL, is a major risk factor for atherosclerosis. In Ayurveda, it is correlated with Shonita Abhishyanda, a condition arising from Santarpana Nidana such as heavy diet, sedentary lifestyle and incompatible food (Viruddhara) leading to excessive Kapha and Meda in Rasa-Raktavaha Srotas as mentioned in Charaka Samhita, leading to Medoroga. Being Santarpanajanya Vyadhi it requires Apatarpana chikitsa along with srotoshodhana. Basti therapy is considered Ardha Chikitsa has Lekhana, Chedana and Apatarpana properties that helps in reducing pathological meda and correcting agni. Hence Vachadi Gana and Haridradi Gana are indicated in Medoj and Kaphaja Vikara (i.e. Dyslipidemia) in Shodhanadi Gana adhyaya of Ashtanga Hridyam. In the present trial 30 patients will be enrolled who are diagnosed with Dyslipidemia fulfilling the inclusion and exclusion criteria and dividing them into two groups of 15 each. Group A will receive Vachadi Gana Kala Basti and Group B will receive Haridradi Gana Kala Basti each with a single sitting of 16 days. Clinical outcomes and biochemical parameters ( Lipid Profile including Total Cholesterol, Triglycerides, LDL and HLD) will be assessed to evaluate the efficacy of two interventions. This study aims to establish effective Ayurvedic Treatment approaches for the management of Dyslipidemia under the topic "Comparative Clinical Evaluation of Vachadi Gana and Haridradi Gana Kala Basti in Dyslipidemia." |