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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   
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Those who have experience in post natal care 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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. 
 
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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