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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-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
2Intervention ArmProcedure-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
 
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." 
 
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