| CTRI Number |
CTRI/2025/04/084368 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to understand the effect of Marichadi vati in the managementof Medodushti with special reference to Dyslipidemia. |
|
Scientific Title of Study
|
A Randomized controlled clinical study to assess the efficacy of Marichadi Vati (Combination of Maricha, Vidanga, Musta with Guggulu) in management of Medodushti with special reference to 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 Harish Digambar Raut |
| Designation |
PG Scholar |
| Affiliation |
R.A. Podar hospital, worli |
| Address |
OPD No.18, Kayachikitsa Department, M.A. Podar Hospital,R.A.Podar Govt(Ayu) college, Worli, Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9527056938 |
| Fax |
|
| Email |
harishraut0707@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Bansi Kadlaskar |
| Designation |
Professor |
| Affiliation |
R.A. Podar Govt(Ayu) Medical College, Worli, Mumbai-18 |
| Address |
OPD No.18, Kayachikitsa Department,R.A.Podar Govt(Ayu) college, Worli, Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9422330084 |
| Fax |
|
| Email |
drkadlaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat Bansi Kadlaskar |
| Designation |
Professor |
| Affiliation |
R.A. Podar hospital, worli |
| Address |
OPD No.18, Kayachikitsa Department, M.A. Podar Hospital,R.A.Podar Govt(Ayu) college, Worli, Mumbai-18
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9422330084 |
| Fax |
|
| Email |
drkadlaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No.18,Kayachikitsa Department, M.A.Podar Govt(Ayu) college, Worli, Mumbai-!8 |
|
|
Primary Sponsor
|
| Name |
R A Podar Medical (Ayu) College, Worli, Mumbai |
| Address |
R A Podar Govt(Ayu) College, Worli, Mumbai-18 Dr. Anie Besant Road Pin code-400018 |
| 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 Harish Digambar Raut |
Mahadevi Anandilal Podar Govt Hospital |
OPD No.18, Kayachikitsa Department, M.A. Podar Hospital,R.A.Podar Govt(Ayu) college, Worli, Mumbai-18
Mumbai
MAHARASHTRA |
9527056938
harishraut0707@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS Committee of institution, R A Podar Govt Ayu college, Worli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Marichadi Vati, Reference: Ashtang Sangrah Sutra Sthana 16, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -Koshna Jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Atorvastatin 10mg | Tab Atorvastatin 10 mg OD after dinner |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Obese Dyslipidemic and Non-obese Dyslipidemic Patients (BMI-18.50 to 40.00kg/m2) as per latest updated WHO classification of BMI.
According to NCEP ATP classification, the pilot project study by prevalence in local area and with the guidelines of CCRAS for Dyslipidemia; following are the levels to be selected for said project.
1) Patient having Serum Total Cholesterol Level 200-239 mg/dl.
2) Patient having Serum LDL Cholesterol Level 130-159 mg/dl.
3) Patient having Serum VLDL Cholesterol Level 40-60 mg/dl.
4) Patient having Serum HDL Cholesterol Level 20-40 mg/dl.
5) Patient having Serum Triglyceride Level 150-190 mg/dl.
|
|
| ExclusionCriteria |
| Details |
1) Pregnant and Lactating mothers.
2) Patients having Diabetes Mellitus.
3) Patients having history of Respiratory Diseases, Coronary Heart Diseases, Renal Diseases etc.
4) Patients having acute complications like Hypertension (BP- 150/90 mm of Hg in those with age 60 and older;and 140/90 mm of Hg for adults less than 60 yrs (According to Eight joint National Committee Guideline)
5) Patients having Hepatitis.
6) Patients having disorders like Carcinoma anywhere in the body etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the clinical efficacy of “Marichadi Vati (Combination of Maricha, Vidanga, Musta
with Guggulu)” in “Medodushti” with special reference to Dyslipidemia. |
For 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To observe the effect of ‘Marichadi Vati (Combination of Maricha, Vidanga,
Musta with Guggulu) ’on Lipid Profile.
2. To compare the effect of ‘Marichadi Vati (Combination of Maricha, Vidanga,
Musta with Guggulu)’ and Tab. Atorvastatin in “Medodushti” with special
reference to Dyslipidemia. |
At 4th & 8th week |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3 |
|
Date of First Enrollment (India)
|
18/04/2025 |
| 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="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
|
Objective- To observe the effect of ‘Marichadi Vati’on Lipid Profile over a period of 8 weeks. To compare the effect of "Marichadi Vati’ and tab. Atorvastin in "Medodushti" with special reference to Dyslipidemia; Design-Randomized controlled clinical trial; Methodology-Marichadi vati (Maricha, Vidanga, Musta and purana gugglu in 1:1:1:3 ratio, 1 gm BD before meal for 8 weeks, tab. Atorvastatin 10 mg HS for 8 weeks, Patients will be screened clinically every week and lipid profile will be repeated every month; Subjective criteria- Shwasa, nidra, Ayasa-akshamata, Jadya, alpabala; Objective criteria- lipid profile observed over 0,4& 8 weeks and graded as mentioned in the synopsis; Statistical considerations-to evaluate the efficacy of trial drug and control drug in numerical data, ’Paired t-test’ will be applied, to compare the efficacy of traial drug and control drug in ordinal data, ’Unpaired t-test’ will be applied, level of significance p<0.05 |