| CTRI Number |
CTRI/2026/01/101321 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
14/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of how well new mothers function after childbirth when they follow Ayurvedic post delivery care, using a standard questionnaire |
|
Scientific Title of Study
|
Evaluation Of Postpartum Maternal Functioning Following Ayurvedic Sutika Paricharya Using The Barkin Index - A Prospective Cohort Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arya P |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department Of Streeroga And Prasutitantra, Government Ayurveda College Tripunithura
Ernakulam KERALA 682301 India |
| Phone |
9778354484 |
| Fax |
|
| Email |
aryapongilody@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor And HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department Of Streeroga And Prasutitantra, Government Ayurveda College Tripunithura
Ernakulam KERALA 682301 India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shahina Mole S |
| Designation |
Professor And HOD |
| Affiliation |
Government Ayurveda College Tripunithura |
| Address |
Department Of Streeroga And Prasutitantra, Government Ayurveda College Tripunithura
Ernakulam KERALA 682301 India |
| Phone |
9495718796 |
| Fax |
|
| Email |
shahinamoleabdulmajeed@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Tripunithura, Ernakulam District, Kerala, India, 682301 |
|
|
Primary Sponsor
|
| Name |
Arya P |
| Address |
PG Scholar, Department Of Streeroga And Prasutitantra, Government Ayurveda College
Tripunithura, Ernakulam, Kerala state, India, 682301 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arya P |
Devi Hospital |
Department Of Obstetrics And Gynecology, Devi Hospital,Tripunithura, 682301 Ernakulam KERALA |
9778354484
aryapongilody@gmail.com |
| Dr Arya P |
Government Ayurveda College Tripunithura |
Department Of Streeroga And Prasutitantra, Ground Floor, Hospital Building, 682301 Ernakulam KERALA |
9778354484
aryapongilody@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Ayurveda College, Tripunithura |
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: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Postpartum women
Delivered a healthy, live new born
Either vaginal or cesarean delivery |
|
| ExclusionCriteria |
| Details |
Women with stillbirth or baby with congenital anomaly
Severe obstetric complications like PPH, eclampsia
Known psychiatric illness before or during pregnancy
Use of psychiatric medications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the change in BIMF scores between the first and sixth postpartum week in women who follow Ayurvedic Sutika Paricharya and those who do not |
First and sixth postpartum week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify association between baseline maternal characteristics ie, age, parity, mode of delivery and BIMF |
First and sixth postpartum week |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
26/01/2026 |
| 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="6" 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
|
The postpartum period is crucial for maternal health, where proper care can significantly impact recovery and long-term wellbeing. Ayurvedic Sutika Paricharya is a traditional postpartum care practice that has been used for generations, but its effectiveness has not been adequately studied using modern assessment methods. This cohort study aims to compare maternal recovery between women who follow Ayurvedic Sutika Paricharya and those who do not.The study will include 70 postpartum women divided into two groups of 35 each. One group will follow traditional Ayurvedic Sutika Paricharya practices, while the other group will not follow these traditional practices and will receive routine postpartum care. Maternal functioning will be measured using the Barkin Index of Maternal Functioning, which evaluates how well mothers are managing their daily activities, caring for their babies, and coping emotionally after childbirth. Assessment will be conducted at two time points: during 1st week post partum and at 6 weeks post partum. This will help track how maternal functioning changes over time in both groups. Statistical analysis will be performed to compare differences between the two groups and examine improvements within each group over the study period. The study expects that women following Ayurvedic Sutika Paricharya will show better maternal functioning scores compared to those not following these practices. The results will provide evidence about whether traditional Ayurvedic postpartum care methods are beneficial for maternal recovery, which could help improve postpartum care approaches for new mothers. |