| CTRI Number |
CTRI/2026/03/107166 [Registered on: 30/03/2026] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of two Ayurvedic medicines Phaltrikadi Ghan Vati and Tryushn Churna in the management of high cholesterol |
|
Scientific Title of Study
|
Randomized comparative clinical study to evaluate the efficacy of Phaltrikadi Ghan Vati and Tryushn Churna in the management of Medorga(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 shanu palaria |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved university Jodhpur rajasthan |
| Address |
Sanjeevani hospital,opd number 6
Post Graduate Institute Of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved university Jodhpur rajasthan.
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8000884576 |
| Fax |
|
| Email |
rajnandanipaldiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brahmanand sharma |
| Designation |
BAMS, M.D.,Ph.D(Ayu.) |
| Affiliation |
Post Graduate Institute Of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved university Jodhpur rajasthan |
| Address |
Sanjeevani hospital,opd number 6
Post Graduate Institute Of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved university Jodhpur rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460318138 |
| Fax |
|
| Email |
bkmudgal9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shanu palaria |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute Of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved university Jodhpur rajasthan |
| Address |
Sanjeevani hospital,opd number 6
Post Graduate Institute Of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved university Jodhpur rajasthan.
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8000884576 |
| Fax |
|
| Email |
rajnandanipaldiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan India 342037 Jodhpur Rajasthan 342037 India |
| Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan India 342037 Jodhpur RAJASTHAN 342037 India |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved Jodhpur Rajasthan |
| Address |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan India 342037 Jodhpur RAJASTHAN 342037 India |
| 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 shanu palaria |
Sanjeevani hospital post graduate Institute of ayurveda jodhpur , Rajasthan |
PG Department Of Kaya Chikitsa Post Graduate Institute Of Ayurved Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan India 342037
Jodhpur
RAJASTHAN |
08000884576
rajnandanipaldiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee dr.sarvepalli radhakrishnan rajasthan ayurved university, jodhpur post graduate institutional ethics 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 | Drug | Classical | | (1) Medicine Name: Phaltrikadi ghan vati , Reference: Vangsen nighantu ratan medari, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: No | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tryushn churna , Reference: Sharangdhara samhita madhyama khanda (6/149-154), Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
) Patients age between 20-70 years of either both of sex.
2) Diagnosed cases of Dyslipidemia & Medoroga on the basis of criteria given (Serum
Cholesterol greater than and equal 200 mg/dl + Total Cholesterol,HDL ratio greater than 4.5)
3) Patients having Clinical signs and symptoms due to Dyslipidaemia. |
|
| ExclusionCriteria |
| Details |
) Age below 20 years and above than 70 years
2) Patients with serious cardiovascular conditions such as unstable angina, recent
myocardial infarction, uncontrolled hypertension (diastolic BP greater than 100 mmHg), or poorly
managed diabetes mellitus.
3) Individuals with compromised kidney function, indicated by serum creatinine levels
equal to or exceeding 2 mg/dL.
4) Patients diagnosed with or suspected of having any form of malignancy and other lifethreatening condition.
5) Pregnant or breastfeeding women, as well as individuals whose dyslipidemia is druginduced (e.g., due to glucocorticoids, diuretics, etc.).
6) Heavy drinkers and drug abusers.
Withdrawal Criteria:
1) During the course of trial if any serious condition or any serious adverse effect occurs |
|
|
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 |
1) Reduction in the level of Serum Triglycerides and Serum LDL.
2) Increase in Serum HDL level |
60 days after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Reduction in weight
2) Reduction in Apolipoprotein B.
3) Qualitative improvement in lifestyle changes |
60 days after treatment. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
There will be selected 46 patients in two groups. In each group there will be 23 patients. Study type -Interventional, Randomised Clinical Trial Allocation -Randomization Level of Study -OPD/IPD
Timing- Prospective
Total duration- 60 days Purpose - I have chosen this subject and medicine because there are very limited comparative study has been done on medoroga[Dyslipidemia] and I want to work on that. |