| CTRI Number |
CTRI/2026/02/103381 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare effectiveness of Chavyadi vati and Vyoshadi vati in management of Medovriddhi with special reference to Hyperlipidemia |
|
Scientific Title of Study
|
A Randomised comparative clinical trial to evaluate the efficacy of Chavyadi vati and Vyoshadi vati in the management of Medovruddhi with special reference to Hyperlipidemia |
| 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 Chaitanya Bapurao Keskar |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
PDEAs college of ayurved and research centre, nigdi, pune |
| Address |
3 rd floor, kayachikitsa department, PDEAs College of Ayurved and research centre,third floor kayachikitsa department, nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
9158642047 |
| Fax |
|
| Email |
chaitanyakeskar001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Taksale |
| Designation |
Professor Kayachikitsa Department |
| Affiliation |
PDEAs college of ayurved and research centre, nigdi, pune |
| Address |
3 rd floor, kayachikitsa department, PDEAs College of Ayurveda and research centre, nigadi pradhikaran, pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9011061293 |
| Fax |
|
| Email |
taksaleabhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Taksale |
| Designation |
Professor Kayachikitsa Department |
| Affiliation |
PDEAs college of ayurved and research centre, nigdi, pune |
| Address |
3 rd floor, kayachikitsa department, PDEAs College of Ayurveda and research centre, nigadi pradhikaran, pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9011061293 |
| Fax |
|
| Email |
taksaleabhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3 rd floor, kayachikitsa department, PDEAs college of ayurved and research centre, nigdi pradhikaran, pune |
|
|
Primary Sponsor
|
| Name |
PDEAs college of ayurved and research centre, nigdi pradhikran, pune |
| Address |
PDEAs college of ayurved and research centre, nigdi pradhikaran, pune 411044 |
| Type of Sponsor |
Private 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 Chaitanya Bapurao Keskar |
Ayurved Rugnalaya and Snowbell Multispeciatlity hospital, Nigdi |
OPD No.117A
Ayurved Rugnalaya and Snowbell Multispeciatlity hospital, Nigdi
Pune
MAHARASHTRA |
9158642047
chaitanyakeskar001@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs college 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: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chavyadi vati, Reference: Vangasena samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Vyoshadi vati, Reference: sharangdhar samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient having 3 or more symptoms of Medovruddhi
1.Swasadhikya
2.Atipipasa
3.Gaurava
4.Balahinata
5.Nidradhikya
Sr.Cholesterol: above 200 mg/dl to 239 mg/dl
Sr.Triglyceride: above 150 mg/dl to 250 mg/dl
LDL: above 130 mg/dl to 159 mg/dl |
|
| ExclusionCriteria |
| Details |
Known case of renal impairment, IHD, TB, AIDS, CA, Cerebral disease,
Hepatitis, hypothyroidism.
Known cases of uncontrolled diabetes mellitus (HbA1c above 9%).
Known case of autoimmune diseases and taking steroid therapy.
Obesity due to secondary causes.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy between Chavyadi Vati and Vyoshadi Vati in reducing
serum lipid parameters (Total cholesterol, LDL, Triglycerides) in patients with
Medovruddhi and hyperlipidemia |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To monitor and document the adverse effects of Chavyadi Vati and Vyoshadi
Vati in the management of Medovruddhi, if any |
30 days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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="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
|
Hyperlipidemia refers to an abnormal increase in lipid levels—mainly
cholesterol and triglycerides—in the blood. It is often linked to poor diet,
sedentary lifestyle, obesity, stress, and genetic predisposition. From an Ayurvedic perspective, hyperlipidemia closely aligns with "Medo
Vriddhi", a condition characterised by an abnormal increase in Meda Dhatu
(adipose tissue or fat) due to vitiation of Kapha dosha and imbalance in
metabolism (Agni). In Ayurveda, such imbalances not only affect the physical
body but also disturb the equilibrium of the doshas, leading to a cascade of
metabolic and systemic disorders. Vangasen advised Chavya, Jirak, trikatu, Hingu, Sauvrachal,
and Chitrak churna with anupan Mastu. Above all, the ingredients have
properties of Kaphaghanta, Deepan, and most of them are Ushna and Katu. So
this combination is taken to cause sampraptibhanga. Due to all these
properties, management of Medovruddhi may be possible, and it may also help
in the growth of saar Medadhatu and lead to healthy individuals. Vyoshadi vati
is a mostly used and quite famous drug, hence it will be taken as a comparative
group. This formulation possesses all the properties of a potent medicine
useful for lowering Medovruddhi symptoms. To make Chavyadi vati suitable and easy to consume To study the efficacy of ‘Chavyadi vati’ and ‘Vyoshadi vati’ in
hyperlipidemia in Medovruddhi, this study is designed. All the ingredients of this formulation are easily available. Therefore,
this formulation is chosen for the present study. |