| CTRI Number |
CTRI/2025/04/085379 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study Of Effect Of Vrikshamla With Shuddha Guggulu In Hyperlipidaemia With Special Reference To Medovriddhi |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study Of Add On Effect Of Vrikshamla With Shuddha Guggulu In Hyperlipidaemia With Special Reference To Medovriddhi |
| 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 Mrunali Shrirang Bharate |
| Designation |
PG Scholar Kayachikitsa |
| Affiliation |
Government Ayurved College,nanded |
| Address |
Government Ayurved College,nanded
Department Of Kayachikitsa Government Ayurvedic College Nanded Maharashtra India 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
09130404633 |
| Fax |
|
| Email |
mrunalibharate7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya S Boinwad |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College,nanded |
| Address |
Government Ayurved College,nanded
Department Of Kayachikitsa Government Ayurvedic College Nanded Maharashtra India 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
9503609432 |
| Fax |
|
| Email |
vidya.shyam.kore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya S Boinwad |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College,Nanded |
| Address |
Government Ayurved College, Nanded
Department Of Kayachikitsa Government Ayurvedic College Nanded Maharashtra India 431601
Nanded
MAHARASHTRA
431601
India |
| Phone |
9503609432 |
| Fax |
|
| Email |
vidya.shyam.kore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College Vazirabad Nanded Maharashtra India 431601 |
|
|
Primary Sponsor
|
| Name |
Dr MRUNALI SHRIRANG BHARATE |
| Address |
Department Of Kayachikitsa Government Ayurvedic College Nanded Maharashtra India 431601 |
| 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 MRUNALI SHRIRANG BHARATE |
Government Ayurvedic college and Hospital, Nanded |
Department Of Kayachikitsa Government Ayurvedic College Nanded Maharashtra India 431601
Nanded
MAHARASHTRA |
09130404633
mrunalibharate7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUIONAL ETHICAL COMMITTEE GOVERNMENT AYURVED COLLEGE NANDED |
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: vrikshamla with shuddha guggulu, Reference: Bhavprakash nighantu amradiphalvarga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: koshn jala), Additional Information: -(2) Medicine Name: shuddha guggulu, Reference: Bhavprakash nighantu karpuradi varga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: koshn jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shudhha guggulu, Reference: Bhavprakash nighantu karpuradi varga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients as per above diagnostic criteria
2. Age between 18 to 60 yrs of either gender.
3. Patients BMI between 25 to 35
4. Patient willing for trial, irrespective of socioeconomic condition. |
|
| ExclusionCriteria |
| Details |
1. Pregnant females and lactating mothers.
2. Subjects suffering from any critical illness that is cardiovascular diseases, renal
impairments.
3. Subjects not willing for trial.
4. Patients on Glucocorticoids, statins
5. Patients with uncontrolled diabetes mallitus |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the add on effect of Vrikshamla with Shuddha guggulu on -
Serum total Cholesterol
Serum Triglycerides
Serum High density lipoprotein
Serum Low Density
Serum very low density lipoprotein |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the add on effect of Vrikshamla with Shuddha guggulu on -
BMI
Shram Shwas
Chala Sphik-udar-stan |
30days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
04/05/2025 |
| 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="2"
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
|
This study is Randomized,Controlled,Clinical, study of add on effect of vrikshmla 500mg bd with guggulu 1gm bd for 30days in pateints of medovridhi with special reference to hyperlipidemia .This study is conducted as PG course at single centre. The primary outcome is to evaluate the effect of vrikshmla on hyperlipidemia. |