| CTRI Number |
CTRI/2024/07/071727 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
ashwattha pallava churna in medoroga with special referance to dyslipidemia |
|
Scientific Title of Study
|
A randomized open labelled single arm clinical study of Ashwattha pallava churna in 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 Sahil Bhavsar |
| Designation |
PG Scholar |
| Affiliation |
Taranath Government Ayurvedic Medical College |
| Address |
Department of PG studies in Dravyaguna, Taranath Government Ayurvedic Medical College, Ballari, Karnataka
Bellary
KARNATAKA
583101
India |
| Phone |
9898417304 |
| Fax |
|
| Email |
shbhavsar16698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekhar Ganiger |
| Designation |
HOD |
| Affiliation |
Taranath Government Ayurvedic medical College and Hospital |
| Address |
Department of PG studies in Dravyaguna, Taranath Government Ayurvedic Medical College, Ballari, Karnataka
Bellary
KARNATAKA
583101
India |
| Phone |
9448234194 |
| Fax |
|
| Email |
rsganiger@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhav Diggavi |
| Designation |
HOD |
| Affiliation |
Taranath Government Ayurvedic medical College and Hospital |
| Address |
Department of PG studies in Kayachikitsa, Taranath Government Ayurvedic Medical College, Ballari, Karnataka
Bellary
KARNATAKA
583101
India |
| Phone |
9844094290 |
| Fax |
|
| Email |
drmvdbly@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dravyaguna Taranath government ayurvedic medical college and hospital Ballari Karnataka India 583101 |
|
|
Primary Sponsor
|
| Name |
Dr. Sahil Bhavsar |
| Address |
Department of Dravyaguna, Taranath Government Ayurvedic Medical College, Ballari, Karnataka |
| 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 Sahil Bhavsar |
Taranath Government Ayurvedic Medical College and Hospital |
Room no 1 Kayachikitsa OPD Department Taranath Government Ayurvedic Medical College and Hospital
Dr rajkumar road
Bellary
KARNATAKA |
9898417304
shbhavsar16698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Taranath Govt. Ayurvedic Medical College Ballari |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E788||Other disorders of lipoprotein metabolism. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwattha pallava, Reference: Yogratnakara Purvardha Raktapitta chikitsa adhyaya 50th shloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)BMI between 25 to 38.9 kg/m2 .
2)Dyslipidemia associated disorders like Non-insulin dependent diabetes mellitus [NIDDM]- RBS up to 200 mg/dl.
Coronary artery disease [CAD]
P/H/O myocardial infarction Hypertension
B.P. up to 160/100 mmHg
|
|
| ExclusionCriteria |
| Details |
1)Patients with HIV, HbsAg or any infective disorders
2) Patients undergone cardiac surgeries like coronary artery bypass graft [CABG], angioplasty, open heart surgery etc.
3)BMI less than 24 kg/m2 and more than 39 kg/m2 .
4)Chronic severe disorders like Chronic renal failure. Severe type 2 diabetes mellitus- RBS more than 200mg/dl. Severe hypertension – more than 160/100 mmHg.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lipid profile |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| All outcomes which effect the quality of life. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/08/2024 |
| 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="5"
Days="29" |
|
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, open labelled, single arm clinical study evaluating the safety and efficacy of Ashwattha Pallava Churna (Ficus religiosa Linn.) 5 gm BID for 60 days in 40 randomly selected patients from the hospital of Taranath Goverrnment Ayurvedic Medical College and Hospital Ballari, Karnataka. |