| CTRI Number |
CTRI/2020/06/026173 [Registered on: 26/06/2020] Trial Registered Prospectively |
| Last Modified On: |
27/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Arjuna Ksheerapaka Churna for managing high lipid level in the body |
|
Scientific Title of Study
|
A Pre-clinical and Clinical study to Evaluate the Efficacy of Arjuna Ksheerapaka Churna in the Management of Medoroga w.s.r. to Dyslipidemia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Vijay Chaudhary |
| Designation |
HOD, Kayachikitsa Department |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Dist. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vijay Chaudhary |
| Designation |
HOD, Kayachikitsa Department |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Dist. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Vijay Chaudhary |
| Designation |
HOD, Kayachikitsa Department |
| Affiliation |
RGGPG Ayurvedic College and Hospital, Paprola |
| Address |
RGGPG Ayurvedic College and Hospital, Paprola, Dist. Kangra, H.P.
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418130228 |
| Fax |
|
| Email |
drvijaychaudhary@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSIR-IHBT, Palampur, Kangra,HP |
| Herbal Garden and Herbarium, Research Institute in ISM, Jogindernagar, Mandi, HP |
|
|
Primary Sponsor
|
| Name |
RGGPG Ayurvedic College |
| Address |
RGGPG Ayurvedic College and Hospital Paprola Kangra, HP 176115 |
| Type of Sponsor |
Government medical 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 |
| Prof Dr Vijay Chaudhary |
IPD and OPD, Department of Kayachikitsa |
RGGPG Ayurvedic College and Hospital, Paprola
Kangra
HIMACHAL PRADESH |
9418130228
drvijaychaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC (Human) RGGPG Ayurvedic College and Hospital, Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arjuna Ksheerapaka Churna |
3 grams twice a day orally for 8 weeks duration |
| Comparator Agent |
Tablet Rosuvastatin |
10 mg once a day (before bed) for 8 weeks duration |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Diagnosed and confirmed cases of dyslipidemia on the basis of investigations.
b) Patient between the age group of 20-70 years of either sex who will fulfill the criteria of diagnosis.
|
|
| ExclusionCriteria |
| Details |
a) Patient not willing for the trial.
b) Patients suffering from major systemic illness necessitating long term treatment (R.A., PTB, malignancy).
c) Poorly controlled hypertensive patients (SBP ≥ 140 mm of Hg and/or DSB ≥ 90 mm of Hg).
d) Patient having past history of MI and unstable angina.
e) Patients having concomitant disorders like ischemic heart disease, congestive heart failure, acute renal failure, chronic renal failure etc.
f) Patients below 20 years and above 70 years of age.
g) Patients who are participating in any other clinical trial or have completed participation during the past three months.
h) Any condition which the investigator thinks may compromise with the safety of the subject.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of objective and subjective criteria |
56 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Control of Lipid Profile |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| Date of Study Completion (India) |
16/04/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
I would like to publish my research trial after its completion as soon as possible. A total of 30 subjects will be studied in two groups: reference control group and trial group. The outcome will be analysed based on subjective and objective parameters with appropriate statistical tools. |