CTRI Number |
CTRI/2021/05/033550 [Registered on: 11/05/2021] Trial Registered Prospectively |
Last Modified On: |
|
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
A study on Traditional Postnatal care practices of Kerala State |
Scientific Title of Study
|
A STUDY ON TRADITIONAL POSTNATAL CARE PRACTICES OF KERALA STATE IN VIEW OF AYURVEDA PRINCIPLES - A CROSS SECTIONAL STUDY |
Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr DIVYAMOL MD |
Designation |
PG scholar |
Affiliation |
All India Institute of Ayurveda |
Address |
Room no 405
4th floor
Department of Stri Roga and Prasuti tantra
Academic block
All India Institute of Ayurveda
Gautampuri
Sarita vihar
New Delhi
South West
Delhi
110076
India
South DELHI 110076 India |
Phone |
08086604232 |
Fax |
|
Email |
divyadam16@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr KAMINI DHIMAN |
Designation |
Associate Professor |
Affiliation |
All India Institute of Ayurveda |
Address |
Room no 405
4th floor
Department of Stri Roga and Prasuti tantra
Academic block
All India Institute of Ayurveda
Gautampuri
Sarita vihar
New Delhi
South West
Delhi
110076
India
South DELHI 110076 India |
Phone |
8920900968 |
Fax |
|
Email |
kd44ayu@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr ANIL KUMAR |
Designation |
Research Advisor |
Affiliation |
All India Institute of Ayurveda |
Address |
Room no 313
Academic block
All India Institute of Ayurveda
Gautampuri
Sarita vihar
New Delhi
South West
Delhi
110076
India
South DELHI 110076 India |
Phone |
9719459437 |
Fax |
|
Email |
dranil250158@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Ayurveda
Gautampuri
Sarita vihar
110076 |
|
Primary Sponsor
|
Name |
All India Institute of Ayurveda |
Address |
All India Institute of Ayurveda
Gautampuri
Sarita Vihar
110076 |
Type of Sponsor |
Research institution and hospital |
|
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 DIVYAMOL M D |
ALL INDIA INSTITUTE OF AYURVEDA |
DEPARTMENT OF
STRI ROGA AND PRASUTI TANTRA
ALL INDIA INSTITUTE
OF AYURVEDA
GAUTAMPURI
MATHURA ROAD
SARITA VIHAR NEW
DELHI 110076
South
DELHI South DELHI |
08086604232
divyadam16@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Those who have experience in post natal care |
|
Intervention / Comparator Agent
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. Females who have delivered a full term baby and followed postnatal care during their Postnatal period within 5 years of time period.
2. Elderly females of a house who have given care to at least 50 postnatal females.
3. Local health workers who have given care to at least 50 postnatal females.
4. Ayurveda doctors of the particular places who have given care to at least 50 postnatal females.
5. Females and Practitioners willing to include in a study. |
|
ExclusionCriteria |
Details |
1. Subjects who are not willing for the trial.
2. Females with child of greater than 5 years of age. |
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Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Information on Traditional postnatal Care practices of Kerala state. |
1- 8 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Analysis on Traditional postnatal care of Kerala state in view of Ayurveda Principles |
1- 3 months |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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)
|
17/05/2021 |
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="1" 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
|
Postnatal period is an important phase of transition in the life of females. Although care of a pregnant woman after delivery is a traditional practice in India, it is having diversity according to the geographical variation of the country. According to WHO, 80% of people in developing countries still relies on traditional medicine to meet their primary health needs. Ayurveda also advocates the management of puerperal woman per Desha of that particular woman. Researches indicates that PNC services utilization is affected by several factors such as maternal age, educational level of woman, mode of delivery etc. In India, most of the people are following traditional practices for their postnatal care along with the contemporary treatment. Among them, people of Kerala are following traditional practices since ages to protect mother as well as neonate. Lack of enough documentation in this field is a lacuna. So it is very important to collect and preserve traditional knowledge about postnatal care. This study is a useful prelude towards the documentation of traditional knowledge for the future generation also.
METHODOLOGY
Study Type- Survey Study Study Design - Cross sectional study Study Population - People of Kerala Sample Size - 300 Sampling Technique- Purposive Sampling Data Collection - Through Direct-in-depth Interview Study Tool - Self Administered Questionnaire
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