| CTRI Number |
CTRI/2024/07/071403 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out the result of garbhashoshahar yoga in garbhashosha |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Garbhashoshahara Yoga Orally and in the form of Ksheer Basti in Garbhashosha w.s.r to Asymmetrical Intra Uterine Growth Restriction |
| 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 Charu Lata |
| Designation |
Lecturer M.D Ayurveda Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Department of Prasuti Tantra Evum Stree Roga Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8411840183 |
| Fax |
|
| Email |
charugupta_sol@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Lata |
| Designation |
Lecturer M.D Ayurveda Department of Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Department of Prasuti Tantra Evum Stree Roga Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Distt Kangra HP
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Distt Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8411840183 |
| Fax |
|
| Email |
charugupta_sol@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrShubhangi Sood |
| Designation |
PG Scholar Prasuti Tantra Evum Stree Roga |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Department of Prasuti Tantra Evum Stree Roga Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
8278838602 |
| Fax |
|
| Email |
shubhi18sood@gmail.com |
|
|
Source of Monetary or Material Support
|
| Charak Pharmacy Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra,
HP Research institute in ISM Joginder Nagar ,Distt Mandi hp
INDIA,176115
|
|
|
Primary Sponsor
|
| Name |
Principal |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP 176115 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| HOD Department of Prasuti Tantra evum Stree Roga |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola HP |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Charu Lata |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP |
Department of PTSR.OPD Room no.211 and IPD Room no.804, Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola Distt Kangra HP
Kangra
HIMACHAL PRADESH |
8411840183
charugupta_sol@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee( Human)Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O251||Malnutrition in pregnancy. Ayurveda Condition: GARBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Garbhashoshahar yoga, Reference: Ashtang sangrah chikitsasthan 23/10, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: luke warm milk), Additional Information: | | 2 | Comparator Arm | Procedure | - | AsthApana-bastiH/ nirUha-bastiH, आसà¥à¤¥à¤¾à¤ªà¤¨-बसà¥à¤¤à¤¿à¤ƒ/ निरूह-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushrut sutrasthan 15, Procedure details: Matra Basti followed by Ksheer Basti with Garbhashoshahara Yoga Dravya in pregnant women for 3 consecutive days.
2 cycles of Ksheer Basti will be given at interval of 15 days )
(1) Medicine Name: Gabhashoshahara Yoga, Reference: Ashtang Sangrah chikitsasthan 23/10, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 250(ml), Frequency: od, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Pregnant women of gestational age in between 31-35 weeks willing for trial.
2 Fundal height less than period of amenorrhea.
3 USS suggestive of Asymmetrical IUGR.
4 BPP SCORE ≥8 |
|
| ExclusionCriteria |
| Details |
1 Pregnant women not willing for the trial.
2 Symmetrical IUGR.
3 Chronic hypertension.
4 Pregnancy induced hypertension.
Gestational diabetes.
5 Impaired renal functions.
• Thyroid dysfunction
• Gestational diabetes.
• BPP SCORE≤6.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Garbhashosha Treatment |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in associated problems related to maternal pregnancy |
2 months |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Research report will be soon published after the completion of trial. 30 patients fulfilling the inclusion and exclusion criteria will be randomly selrcted from OPD and IPD of department of Prasuti tantra evum Stree roga,RGGPG Ayurvedic college and hospital paprola. Patients will be divided randomly into 2 groups ; Group 1 and Group 2 each with 15 patients. Group 1 will be given garbhashoshahar yoga orally Group 2 will be given garbhashoshahar yoga rectally in the form of ksheer basti. Result will be assessed on the basis of assessment criteria. |