| CTRI Number |
CTRI/2025/01/079097 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the effect of Rasonadi kashaya in dyslipidemia |
|
Scientific Title of Study
|
Effectiveness of Rasonadi kashaya in 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 Resmi V |
| Designation |
2nd year pg scholar |
| Affiliation |
Government ayurveda college Thiruvananthapuram |
| Address |
Department of Kayachikitsa Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9847093078 |
| Fax |
|
| Email |
resmiv1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mini V G |
| Designation |
Professor |
| Affiliation |
Government ayurveda college Thiruvananthapuram |
| Address |
Department of Kayachikitsa Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9446380592 |
| Fax |
|
| Email |
mini.tinku@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mini V G |
| Designation |
Professor |
| Affiliation |
Government ayurveda college Thiruvananthapuram |
| Address |
Department of Kayachikitsa Government Ayurveda College
Thiruvananthapuram
Thiruvananthapuram
KERALA
695001
India
Thiruvananthapuram
KERALA
695001
India |
| Phone |
9446380592 |
| Fax |
|
| Email |
mini.tinku@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government ayurveda college Thiruvananthapuram
Kerala
India
695001
|
|
|
Primary Sponsor
|
| Name |
Government ayurveda college Thiruvananthapuram |
| Address |
Government ayurveda college Thiruvananthapuram
695001 |
| Type of Sponsor |
Other [Government ayurveda 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 |
| DrResmi V |
Government ayurveda college |
OP number 2
Department of
Kayachikitsa
Government Ayurveda
College
Thiruvananthapuram
Thiruvananthapuram
KERALA
Thiruvananthapuram
KERALA |
9847093078
resmiv1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL COMMITTEE FOR ETHICS IN RESEARCH GOVERNMENT AYURVEDA COLLEGE THIRUVANANTHAPURAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E780||Pure hypercholesterolemia. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasonadi kashaya , Reference: Sahasrayogam , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of the age group 25-60 years
On NCEP ATP III guidelines basis, having serum total cholesterol level 200-239mg/dl, LDL-
130-159 mg/dl |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of CAD, Renal disorders
Diagnosed cases of Diabetes mellitus and thyroid dysfunction.
Diagnosed cases of Dyslipidemia under medication
Patients with Acid peptic disorders, GERD, Bleeding disorders |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in serum lipid level. |
Assessment will be done on 0 th and 31st day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2025 |
| 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
|
The above study deals with assessing the effect of Rasonadi kashaya in Dyslipidemia. Evaluation is made on the changes in serum lipid level. Assessment will be done on 0 th and 31 st day |