| CTRI Number |
CTRI/2025/07/090022 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Yoga and pranayam] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of garbhasanskara in second trimester of pregnancy. |
|
Scientific Title of Study
|
Randomized Controlled Trial to Evaluate the Efficacy of Kashmarya-Madhuka Granules Along with Yoga & Pranayama as an Aspect of Garbhasanskara in Second Trimester of Pregnancy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yogita Kumari |
| Designation |
M. S. Scholar |
| Affiliation |
Madan Mohan Malviya Government Ayurveda College, Udaipur |
| Address |
PG Dept. of Prasuti Tantra Evam Striroga,
Madan Mohan Malviya Government Ayurved College,
Radaji Circle,
Ambamata,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
6375776201 |
| Fax |
|
| Email |
dryogita.ptsr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anu M S |
| Designation |
Lecturer / Assistant Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur |
| Address |
PG Dept. of Prasuti Tantra Evam Striroga,
Madan Mohan Malviya Government Ayurved College,
Radaji Circle,
Ambamata,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8780511929 |
| Fax |
|
| Email |
dranuvaidhya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anu M S |
| Designation |
Lecturer / Assistant Professor |
| Affiliation |
Madan Mohan Malviya Government Ayurved College, Udaipur |
| Address |
PG Dept. of Prasuti Tantra Evam Striroga,
Madan Mohan Malviya Government Ayurved College,
Radaji Circle,
Ambamata,
Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
8780511929 |
| Fax |
|
| Email |
dranuvaidhya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt. Ayurved College, Radaji Circle, Ambamata, Udaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Govt. Ayurved College |
| Address |
Madan Mohan Malviya Govt. Ayurved College, Radaji Circle, Ambamata, Udaipur, Rajasthan 313001 |
| 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 |
| Dr Yogita Kumari |
Madan Mohan Malviya Government Ayurveda College And Hospitals, Udaipur |
OPD no. 06, Government Ayurveda Hospital, Motichohattah, Udaipur (Affiliated hospital of Madan Mohan Malviya Government Ayurved College)
Udaipur
RAJASTHAN |
6375776201
dryogita.ptsr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M. M. M. Govt. Ayurved College, Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z349||Encounter for supervision of normal pregnancy, unspecified. Ayurveda Condition: GARBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | | IFA tab (60 mg of elemental iron and 0.5 mg of folic acid)
Calcium tab
(500 mg of Calcium with 250 I.U. Vitamin D3)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kashmarya Madhuka Granules, Reference: Charak Samhita, Chikitsa sthan, Chapter-28/15-16, Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Cow milk (Godugdha)), Additional Information: Intervention also includes Yoga & Pranayama as per SOP in Preconceptional and Prenatal Care Through Ayurveda Published by AIIA, New Delhi and routine ANC Supplementation - IFA tab (60 mg of elemental iron and 0.5 mg of folic acid) Calcium tab (500 mg of Calcium with 250 I.U. Vitamin D3) |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.All pregnant women with known LMP between 13th -20th weeks of pregnancy.
|
|
| ExclusionCriteria |
| Details |
1.Patients with hemoglobin less than 7gm%.
2.Pregnancy with uterine malformations and congenital defect of uterus.
3.Multiple pregnancy.
4.Pregnancy with uterine fibroid and carcinoma.
5.Pregnancy with cardiovascular diseases.
6.Pregnancy with known case of epilepsy.
7.Pregnant women who is under antipsychotics.
8.Pregnancy with any severe systemic illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Fetal wellbeing – assessed through fetal biometry with USG
2.Maternal wellbeing – assessed with Mid Upper Arm Circumference, Pregnancy Weight Gain etc. |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in maternal minor ailments.
2.Changes in the rate of complications in the second trimester of pregnancy.
3.Changes in maternal stress.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/07/2025 |
| 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="9"
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
|
This study is about a clinical evaluation of Kashmarya Madhuka granules along with Yoga and Pranayama as an aspect of Garbhasanskara in the second trimester of pregnancy with routine antenatal care (ANC), in comparison to routine antenatal care (ANC) alone. There will be 2 groups in the study- Group A (Trial group): Will receive Kashmarya-Madhuka granules (5g twice daily after meals with Godugdha) for 12 weeks along with Yoga and Pranayama as per national prenatal protocols with IFA tab (60 mg of elemental iron and 0.5 mg of folic acid) and Calcium tab (500 mg of Calcium with 250 I.U. Vitamin D3). Group B (Control group): IFA tab (60 mg of elemental iron and 0.5 mg of folic acid) and Calcium tab (500 mg of Calcium with 250 I.U. Vitamin D3). Trial will be conducted for a period of 12 weeks (3 months). Follow-up will be done every 15 days with final assessment after 12 weeks based on subjective symptoms, objective parameters and lab investigations. Outcome assessment will include Primary outcomes: Fetal growth parameters (BPD, HC, AC, FL, AFI) and maternal nutritional status (weight gain and MUAC). Secondary outcomes: Changes in common pregnancy complaints, maternal stress levels (PSS scale), and incidence of complications such as IUGR and pre-eclampsia. The data will be analysed scientifically and statistically. |