| CTRI Number |
CTRI/2025/02/080520 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Garbhasanskar] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of Phalasarpi and Anuloma-Viloma Pranayama on the maternal and foetal well-being during pregnancy |
|
Scientific Title of Study
|
Two Arm, Randomized, Open Labelled, Comparative Clinical Study to assess the efficacy of Phalasarpi and Anuloma-Viloma Pranayama on the Maternal and Fetal Well Being during Pregnancy |
| Trial Acronym |
Phalasarpi and Anuloma-Viloma Pranayama on the maternal and foetal well-being during pregnancy |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhappil Sharma |
| Designation |
Ph. D. Scholar, Associate Professor |
| Affiliation |
Gangasheel Ayurvedic Medical College and Hospital, Kamua Kala Bareilly |
| Address |
OPD No. 3, Dept of Prasutitantra and Streeroga, Gangasheel Ayurvedic Medical College and Hospital, Kamua Kala Bareilly
Bareilly
UTTAR PRADESH
243123
India |
| Phone |
7018687930 |
| Fax |
|
| Email |
drbhapilsharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Ramugade |
| Designation |
Professor and Head, Dept of PTSR |
| Affiliation |
D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai |
| Address |
OPD. No. 4, Dept of Prasutitantra and Streeroga, D. Y. Patil Ayurvedic Hospital - D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9324446071 |
| Fax |
|
| Email |
divya.ramugade@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Ramugade |
| Designation |
Professor and Head, Dept of PTSR |
| Affiliation |
D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai |
| Address |
OPD. No. 4, Dept of Prasutitantra and Streeroga, D. Y. Patil Ayurvedic Hospital - D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9324446071 |
| Fax |
|
| Email |
divya.ramugade@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| VYDS Ayurved College
Dharpa, (Khurja-Bulandshahr G.T. Road)
Khurja (U.P.) - 203131
|
|
|
Primary Sponsor
|
| Name |
Dr. Bhappil Sharma |
| Address |
VYDS Ayurved College
Dharpa, (Khurja-Bulandshahr G.T. Road)
Khurja (U.P.) - 203131 |
| Type of Sponsor |
Other [Self Funded Ph. D. Research Work] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| No |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhappil Sharma |
VYDS Ayurved College Dharpa, (Khurja-Bulandshahr G.T. Road) Khurja (U.P.) - 203131 |
OPD No. 3, Dept of PTSR
VYDS Ayurved College
Dharpa, (Khurja-Bulandshahr G.T. Road)
Khurja (U.P.) - 203131
Bulandshahar
UTTAR PRADESH |
7018687930
drbhapilsharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, VYDS Ayurved College Dharpa, (Khurja-Bulandshahr G.T. Road) Khurja (U.P.) - 203131 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O94||Sequelae of complication of pregnancy, childbirth, and the puerperium. Ayurveda Condition: GARBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Conventional Ante-Natal Care | only standard ANC care according to RCH-2 program throughout the pregnancy |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Patient with UPT positive and of age group 21 years to 35 years
2. Patient with UPT positive and confirmed uterine gestation with USG irrespective of their parity28
3. Patient with UPT positive confirmed uterine gestation with USG will be enrolled within 2 months of her LMP
4. UPT positive patient who is willing to consume Phala-Sarpiand performAnuloma-Viloma Pranayama
|
|
| ExclusionCriteria |
| Details |
Patients with Pre-diagnosed underlaying pathology or a systemic disease.
2. Patients not willing to perform Garbhasanskara.
3. Patients with mental disorders like schizophrenia.
4. Patients of younger than 21 years and elder than 40 years of age.
5. Patients with any pre-existing tumour related to reproductive system.
6. Previous 2 LSCS. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
full term normal vaginal delivery of a baby without any complications
|
Baseline - before 8 weeks with UPT positive and confirmed uterine gestation with USG, 11th or 12th week of gestation, 18th or 19th weeks of gestation, 28th week of gestation, 32nd week of gestation,34th week of gestation,36th week of gestation, on the day of delivery of baby
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Infections, Birth asphyxia and trauma, Preterm births and low birth weight and Congenital
malformations and others |
Baseline - before 8 weeks with UPT positive and confirmed uterine gestation with USG
First follow up 11th or 12th week of gestation
Second follow up 18th or 19th weeks of gestation
Third follow up - 28th week of gestation
Fourth follow up - 32nd week of gestation
Fourth follow up 34th week of gestation
Sixth follow up - 36th week of gestation
last follow up - on the day of delivery of baby
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
01/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The results of the study will be published in peer reviewed journal. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Total 66 female participants in the age group of 21 – 35 years with positive Urine Pregnancy Test (UPT) and confirmed uterine gestation with USG irrespective of their parity will be screened according to inclusion and exclusion criteria of the study and included in the study after taking written informed consent. These participants will be explained the procedure provided the information of the patient’s to be confidential. The participants in group A will consume Phalasarpi and perform Anuloma-Viloma Pranayama as follows: The participants will be enrolled and come to the hospital most probably after 5 weeks and will be diagnosed as UPT positive. Also, this group will receive standard ANC care according to RCH-2 Program. Also, Phalasarpi will be administered throughout the pregnancy. These participants will perform Anuloma-Viloma Pranayama. The participants in group B will receive only standard ANC care according to RCH-2 program throughout the pregnancy. · Objective Criteria: will be Pregnancy completed weeks at the time of delivery, Type of Delivery, AFI at the end of 36 weeks, Birth weight of Child, APGAR score at 1 min. of birth, HB% of Mother at the time of delivery, Increase in Maternal weight throughout pregnancy, Foetal weight throughout the pregnancy Specially designed Case Record Form (CRF) based on study protocol.
The study was completed with recruitment of total 66 females - 33 in each group. All female participants were followed till their delivery. No dropouts were there in the present study.The data generated through clinical study was subjected to appropriate statistical tests to derive valid conclusions. |