| CTRI Number |
CTRI/2021/04/032854 [Registered on: 15/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/08/2021 |
| 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
|
A clinical study to evaluate the efficacy of Darvyadi Leha in Kamla in grabhini or jaundice in pregnancy |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Darvyadi Leha in Garbhini Kamla w.s.r. to Intrahepatic Cholestasis Of Pregnancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seema Shukla |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi Govt Post graduate Ayurvedic College and Hospital Paprola |
| Address |
Dept of PTSR, R.G.G P.G. Ayurvedic College And Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Shukla |
| Designation |
Reader |
| Affiliation |
Rajiv Gandhi Govt Post graduate Ayurvedic College and Hospital Paprola |
| Address |
Dept of PTSR, R.G.G P.G. Ayurvedic College And Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9418008833 |
| Fax |
|
| Email |
drseemanil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ekta |
| Designation |
PG scholar |
| Affiliation |
Rajiv Gandhi Govt Post graduate Ayurvedic College and Hospital Paprola |
| Address |
Room No 804, dept of PTSR R.G.G.P.G. Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
09816792356 |
| Fax |
|
| Email |
drekta94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rggpg ayurvedic College and hospital paprola baijnath himachal pradesh |
|
|
Primary Sponsor
|
| Name |
RGG PG Ayurvedic College And Hospital Paprola |
| Address |
R.G.G P.G. Ayurvedic College And Hospital Paprola V.P.O paprola Teh Baijnath Distt Kangra (H.P.) 176115 |
| Type of Sponsor |
Other [Government Ayurvedic 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 |
| Dr Ekta |
Rggpg ayurvedic hospital paprola himachal pradesh |
RAH paprola , room no. 804 department of Prasuti tantra avum stree roga
Kangra
HIMACHAL PRADESH |
9816792356
drekta94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (Human) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O266||Liver and biliary tract disordersin pregnancy, childbirth and the puerperium. Ayurveda Condition: GARBINIROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Darvyadi leha |
Dose : 10gm Bd |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Ursodeoxycholic acid |
14mg/kg/day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patient willing for trial .
Female patient presenting with features of Garbhini kamala
Pregnant females presenting the picture of impaired liver functions |
|
| ExclusionCriteria |
| Details |
Patient not willing for trial
Patient having eclampsia , HELLP ,severe hyperemesis gravidarum, severe pre eclampsia , viral hepatitis , drug induced jaundice , cirrhosis, tumors and other systemic disorders, fatty liver
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fulfillment of subjective and objective criterion |
7-15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Feeling of well being |
7-15 days |
|
|
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)
|
15/04/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet . |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Research report will be soon published after the completion of trial. 30 patients fulfilling the inclusion and exclusion criterias will be randomly selected from the OPD and IPD of Department of Prasuti tantra avum Stree roga, RGGPG Ayurvedic College and Hospital Paprola . Patients will be divided randomly into 2 groups; Group I and Group II each with 15 patients. Group I will be given oral preparation of Darvyadi Leha while Group II will be given oral preparation of Ursodeoxycholic acid. Results will be assessed on the basis of subjective and objective criterias before and after the completion of trial. |