| CTRI Number |
CTRI/2020/06/026061 [Registered on: 23/06/2020] Trial Registered Prospectively |
| Last Modified On: |
02/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of Ayurvedic Formulations in the Management Of Kamala |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy of Eladi Churna And Draksha Ghrita In The Management Of Kamala W.S.R. To Impaired Liver Functions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nill |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSunil Thakur |
| Designation |
Reader |
| Affiliation |
RGGPG Ayurvedic College and Hospital ,Paprola |
| Address |
Rajiv Gandhi Govt. Ayurvedic College and Hospital Deptt. of Kayachikitsa,Room NO.315,Paprola,Tehsil Baijnath,Distt.Kangra(H.P.)
Rajiv Gandhi Govt. Ayurvedic College and Hospital Deptt. of Kayachikitsa,Room NO.315,Paprola,Tehsil Baijnath,Distt.Kangra(H.P).
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSunil Thakur |
| Designation |
M.D.(Ay) Kayachikitsa |
| Affiliation |
RGGPG Ayurvedic College and Hospital ,Paprola |
| Address |
Rajiv Gandhi Govt. Ayurvedic College and Hospital Deptt. of Kayachikitsa,Room NO.315,Paprola,Tehsil Baijnath,Distt.Kangra(H.P.)
Rajiv Gandhi Govt. Ayurvedic College and Hospital Deptt. of Kayachikitsa,Room NO.315,Paprola,Tehsil Baijnath,Distt.Kangra(H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Azra Qureshi |
| Designation |
PG Scholar |
| Affiliation |
RGGPG Ayurvedic College and Hospital ,Paprola |
| Address |
Rajiv Gandhi Govt. Ayurvedic College and Hospital Deptt. of Kayachikitsa,Room NO.315,Paprola,Tehsil Baijnath,Distt.Kangra(H.P.)
Rajiv Gandhi Govt. Ayurvedic College and Hospital Deptt. of Kayachikitsa,Room NO.315,Paprola,Tehsil Baijnath,Distt.Kangra(H.P.)
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7889798655 |
| Fax |
|
| Email |
azraqureshi998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy,Paprola District Kangra,Himachal Pradesh
Charak Pharmacy,RGGPG Ayurvedic College And Hospital,Paprola District Kangra,Himachal Pradesh
Research Institute in I.S.M. Jogindernagar, Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
College Principal |
| Address |
RGGPG Ayurvedic College and Hospital,Paprola |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD |
Department of Kayachikitsa,RGGPG Ayurvedic College and Hospital,Paprola |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunil Thakur |
Rajiv Gandhi Ayurvedic College and Hospital |
Room no. -315 , Department of Kayachikitsa, RGGPG Ayurvedic Medical College and Hospital
Kangra
HIMACHAL PRADESH |
9816195001
dr.skumarthakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC(human)RGGPG Ayurvedic College Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K769||Liver disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Eladi Churna |
3gm twice a day for 3 weeks (yog.ratnakar.pandu chi 11) |
| Comparator Agent |
Eladi Churna and Draksha Ghrita |
3gm twice a day for 3 weeks
(yog.ratnakar.pandu chi 11)
6 gm twice a day for 3 weeks
(charak chi. 16/52) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to undergo trial and ready to give written consent
Patient presenting with classical feature of Kamala and impaired liver functions
Total serum bilirubin-2 to 10 mg/dl
SGOT-50 to 1000 IU/L
SGPT- 50 to 1000 IU/L |
|
| ExclusionCriteria |
| Details |
Patient not willing for trial
Patient below the age of 20 years and above 60 years
Patient having malignancy and acute hepatocellular failure.
Patient requiring surgical intervention(obstructive jaundice)
Total serum bilirubin-<2mg/dl or >10mg/dl
SGOT >1000 IU/L
SGPT >1000 IU/L
S.ALP>3 Times the normal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of subjective and objective criteria |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of subjective and objective criteria |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
28/06/2020 |
| Date of Study Completion (India) |
02/03/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
I would like to publish my research trial after completion of the trial as soon as possible . Patients will be selected from OPD of RGGPG Ayurvedic college and Hospital Paprola .Two groups of 30 patinets will be registered ans assessed on the basis of subjective and objective criteria. |