| CTRI Number |
CTRI/2025/04/085306 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Daruharidra churna and Arogyavardhini vati in Medoroga - abnormal fat level in body |
|
Scientific Title of Study
|
A randomized controlled clinical trial to study the effect of Ayurvedic management with Daruharidra churna and Aarogyavardhini vati on Medoroga 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 Roshan Rushikesh Patil |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
Department of Kayachikitsa SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
7219149298 |
| Fax |
|
| Email |
roshanrpatil1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiraman Nivrutti Warungase |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
Department of Kayachikitsa SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9420364157 |
| Fax |
|
| Email |
hiramanwarungase@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roshan Rushikesh Patil |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
Department of Kayachikitsa SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
7219149298 |
| Fax |
|
| Email |
roshanrpatil1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
422403 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Roshan Rushikesh Patil |
| Address |
Department of Kayachikitsa SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
422403 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
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 Roshan Rushikesh Patil |
SMBT Ayurved college and Hospital |
OPD No 20 Department of Kayachikitsa SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
422403 Maharashtra India
Nashik
MAHARASHTRA |
7219149298
roshanrpatil1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved college and Hospital |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjuna churna, Reference: Bhavaprakasa of Bhavamisra , commentary Prof. K.C. Chunekar, chapter Vatadi varga , shloka 27, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Weeks, anupAna/sahapAna: Yes(details: -Koshnjal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aarogyavardhini vati, Reference: Rasratna samuchchayah of Acharya Shree Vagbhat, by prof. Siddhi Nandan Mishra ,Adhyay 20, sholka 108-112 ,page no. 466, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -Koshnjal), Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Daruharidra churna, Reference: Agnivesh charaksamhita, by Pt .rajeshwara datta shastri,sutrasthan chapter no.4,shloka No.3, page no.74, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Weeks, anupAna/sahapAna: Yes(details: -Koshnjal), Additional Information: - | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aarogyavardhini vati, Reference: Rasratna samuchchayah of Acharya Shree Vagbhat, by prof. Siddhi Nandan Mishra ,Adhyay 20, sholka 108-112 ,page no. 466, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: -Koshnjal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.The patient having age between 18 years to 60 years and irrespective of socioeconomic status, sex and religion.
2. Newly diagnosed Dyslipidemic patients
3. Patient associated with hypertension
4. Patient having Serum Total Cholesterol Level more than or equal to 200mg/dl
5. Patient having Serum Triglyceride Level more than or equal to 150mg/dl
6. Patient having LDL Cholesterol more than or equal to 100 mg/dl
7. Patient having HDL Cholesterol less than or equal to 40 mg/dl . |
|
| ExclusionCriteria |
| Details |
1. The patient having Cardiovascular disease, pulmonary, renal and hepatic
disease etc.
2. pregnant women
3. DYSLIPIDEMIA due to drugs e.g. Anticonvulsant, Beta blockers,Corticosteroid etc
4. Patient having history of metabolic disorders and Endocrine diseases such as Diabetes mellitus ,etc |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Medoroga after ingestion of Daruharidra churna and Aarogyavardhini vati |
7 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 |
|
Date of First Enrollment (India)
|
02/05/2025 |
| 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 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
|
medoroga is defined as a disease , characterized by excessive body fat. On the basis of the symptomatology, Medoroga can be correlated with Dyslipidemia. Dyslipidemia is abnormally elevated levels of any or all lipids or lipoprotein in the blood,associated with other manifestations.The prevalence of Dyslipidemia in India is 15%. Daruharidra churna which have Tikta, Kashay rasa,Katuvipak and ushnavirya and gunas like laghu-Ruksha which are helpful to breakdown pathophysiology of Medoroga.The wood extract of the plant, with chemical constituents such asproto-berberine, isoquinoline, bisbenzyl-isoquinoline, flavonoids and phenolic acid and Aarogyavardhini vati effectively removes excess fat, eliminates toxins, and reduces cholesterol levels in the body which revealed that the study had a vital role in the management of Dyslipidemia. The patients within the age group of 18-60 years who fulfills the clinical diagnostic criteria for Dyslipidemia & having symptoms of Medoroga as mentioned in classics are selected irrespective of sex, socio-economic status, and community, written consent from patient will be taken prior to study. Computerised generated Sampling technique will be used. Total 70 number of patients will be selected and divided into two groups, named as Group A (trial group) and Group B (Control group). Daruharidra churna & aarogyavardhini vati Group A (trial group) with dose 5gm BD for 1st 3 wks and 500mg BD for next 4 wks & anupanan koshna jal and Arjuna churna & aarogyavardhini vati Group B(Control group) with dose 5gm BD for 1st 3 wks and 500mg BD for next 4 wks & anupana koshana jal will be given to patients. Both drugs will be administered in churna & vati form for 7 weeks. Observations will be done on 0 Day,3rd week,7th week. Result of study will be drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased. |