| CTRI Number |
CTRI/2026/01/102295 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Rasona Haritaki Vati in lipid disorder {Medoroga} |
|
Scientific Title of Study
|
A controlled clinical trial to evaluate the efficacy of Rasona Haritaki Vati in the management of Dyslipidemia with special reference to Medoroga |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIHARIKA GAUTAM |
| Designation |
MD Scholar |
| Affiliation |
Faculty of Ayurveda IMS BHU |
| Address |
Department of kayachikitsa IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9407089944 |
| Fax |
|
| Email |
niharikagautam68726@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Antiwal |
| Designation |
Assistant professor |
| Affiliation |
Faculty of Ayurveda IMS BHU |
| Address |
Department of kayachikitsa IMS BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451586325 |
| Fax |
|
| Email |
antiwalmeera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meera Antiwal |
| Designation |
Assistant professor |
| Affiliation |
Faculty of Ayurveda IMS BHU |
| Address |
Department of kayachikitsa IMS BHU Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9451586325 |
| Fax |
|
| Email |
antiwalmeera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa
faculty of Ayurveda Banaras hindu university Varanasi
221005 |
|
|
Primary Sponsor
|
| Name |
BANARAS HINDU UNIVERSITY |
| Address |
LANKA VARANASI Uttarpradesh India 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 NIHARIKA GAUTAM |
Sir sunderlal hospital Banaras hindu university |
Department of Kaychikitsa faculty of ayurveda Banaras hindu university Varanasi
Varanasi
UTTAR PRADESH |
9407089944
niharikagautam68726@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E788||Other disorders of lipoprotein metabolism. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasona Haritaki Vati, Reference: Anubhuta Yoga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Atorvastatin, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 40(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients of age group between 21 to 60 years.
patient willing to enrolled in study. |
|
| ExclusionCriteria |
| Details |
age group less than 21 and more than 60 years of age.
patient not willing for trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be significant improvement in lipid profile of patient.
|
3 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome- Reduction in symptoms of Dyslipidemia and improve quality of life.
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
10/02/2026 |
| 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="0"
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
Modification(s)
|
• Selection .Of .Patients:- .Following .a .comprehensive .history .taking, .clinical, .and laboratory .evaluations, .a .total .no. .of 80 .patients .with .clinical .symptoms .of .Dyslipidemia (Medoroga) .will .be .chosen .from .the .OPD .and .IPD .of .Kayachikitsa, .S. .S. .Hospital, .IMS, .B.H.U., .Varanasi .based .on .inclusion .and .exclusion .criteria. • Duration .of .treatment: .3 .months .with .follow .up .at .30 .days .of . .interval. • DOSE: Rasona Haritaki Vati - 500 mg BD Atorvastatin- 40 mg OD Grouping: Patient .will .be .selected .according .to .the .inclusion .or .exclusion .criteria .and .those .who .are .fulfilling .the .criteria .will .be .randomly .divided .into .two .groups (40 in each group). . • Group .A: .- .Rasona .Haritaki Vati • Group .B: .- .Atorvastatin
|