| CTRI Number |
CTRI/2021/09/036960 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
21/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the garbhini paricharya in 6th and 7th month of pregnanacy. |
|
Scientific Title of Study
|
Randomized Clinical Controlled trial of Sushrutokta Garbhini Paricharya in 6th and 7th month of Preganancy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Radha Harshad Phadnis |
| Designation |
Assistant Professor |
| Affiliation |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Ashta, Tal. Walwa, Dist. Sangli |
| Address |
Dr D Y Patil College OF aYURVEDA AND RESEARCH CENTRE, PIMPARI CHINCHWAD MAHARASHTRA PUNE.
Hon. Shri. Annasaheb Dange Ayurved Medical College, Ashta, Tal. Walwa, Dist. Sangli
Sangli
MAHARASHTRA
411018
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNeeta Mahesekar |
| Designation |
Professor |
| Affiliation |
Dr D Y PATILCOLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPARI PUNE |
| Address |
Dr D Y Patil College OF AYURVEDA AND RESEARCH CENTRE PIMPARI PUNE
Dr D Y PATIL COLLEGE OF AYURVEDA AND RESEARCH CENTRE PIMPARI PUNE
Pune
MAHARASHTRA
411018
India |
| Phone |
9822627092 |
| Fax |
|
| Email |
neeta_mahesekar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Radha Harshad Phadnis |
| Designation |
Assistant Professor |
| Affiliation |
Hon. Shri. Annasaheb Dange Ayurved Medical College, Ashta, Tal. Walwa, Dist. Sangli |
| Address |
Dr D Y Patil College OF AYURVEDA AND RESEARCH CENTRE, PIMPARI CHINCHWAD MAHARASHTRA PUNE.
Hon. Shri. Annasaheb Dange Ayurved Medical College, Ashta, Tal. Walwa, Dist. Sangli
Sangli
MAHARASHTRA
411018
India |
| Phone |
9545114545 |
| Fax |
|
| Email |
radhakulkarni6@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Radha Harshad Phadnis |
| Address |
D Y Patil College Pune |
| 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 Radha Harshad Phadnis |
dr. d. y. patil aurved college and research center , pune |
OPD no 1 Streerog and Prasuti tantra dept dr d y patil aurved college and research center , pune
Pune
MAHARASHTRA |
9545114545
radhakulkarni6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O369||Maternal care for fetal problem, unspecified, (2) ICD-10 Condition: O369||Maternal care for fetal problem, unspecified, (3) ICD-10 Condition:O369||Maternal care for fetal problem, unspecified. Ayurveda Condition: Garbhini Paricharya, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1)Gokshursiddha Ghrita
2)Prithakparnyadi Ghrita
|
Gokshursiddha Ghrita 5ml b.i.d. before meal [Apankal] in 6th month of pregnancy
2] Prithakparnyadisiddha Ghrita 5ml b.i.d. before meal [Apankal] in 7th month of pregnancy |
| Comparator Agent |
1.Ferrous Sulphate 200 mg [contains 60 mg elemental iron] O.D.10
2] Calcium Carbonate 500 mg O.D, In 6th and 7th month of pregnancy |
Ferrous Sulphate 200 mg [contains 60 mg elemental iron] O.D.10
2] Calcium Carbonate 500 mg O.D, In 6th and 7th month of pregnancy |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Women who have completed 5th month of pregnancy
|
|
| ExclusionCriteria |
| Details |
Multiple pregnancy
 k/c/o PIH, gestational diabetes, oligohydramnios, polyhydramnios, APH, STD‟S.
 Pregnancy with congenital fetal anomaly
 Hb % <10 gm% |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
fetal progress according to gestational age
Progress in Garbhini in 6th and 7th month of pregnancy
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| fetal progress according to gestational age |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 2 |
|
Date of First Enrollment (India)
|
15/10/2021 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
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 controlled clinical study in which gokshur siddha ghrita and pruthakparnyadi ghrita along with Ferrous sulphate 200mg OD and Calcium Carbonate 500mg OD will be given in 6th and 7th month of pregnancy as garbhini paricharya. Total 140 Pregnant women fulfiiling inclusion and exclusion criteria will be divided into two groups 70 in each group. Progress in pregnant woman and fetal development will be assessed. |