FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/11/010702 [Registered on: 29/11/2017] Trial Registered Retrospectively
Last Modified On: 28/11/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Health Enhancing]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to evaluate the effect of Sootika Paricharya explained by Charakacharya in postnatal mothers 
Scientific Title of Study   Clinical evaluation of the effect of Charakokta Sootika Paricharya 
Trial Acronym  CCSP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyoti Mallappa Kumbar 
Designation  Head of the department, Reader 
Affiliation  Parul Institute of Ayurved 
Address  Plot number 69, 9th cross, Gokul Nagar, Post: Mutaga, Belgaum

Belgaum
KARNATAKA
591124
India 
Phone  9482628541  
Fax    
Email  drjyotik11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti Mallappa Kumbar 
Designation  Head of the department, Reader 
Affiliation  Parul Institute of Ayurved 
Address  Plot number 69, 9th cross, Gokul Nagar, Post: Mutaga, Belgaum

Belgaum
KARNATAKA
591124
India 
Phone  9482628541  
Fax    
Email  drjyotik11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti Mallappa Kumbar 
Designation  Head of the department, Reader 
Affiliation  Parul Institute of Ayurved 
Address  Plot number 69, 9th cross, Gokul Nagar, Post: Mutaga, Belgaum

Belgaum
KARNATAKA
591124
India 
Phone  9482628541  
Fax    
Email  drjyotik11@gmail.com  
 
Source of Monetary or Material Support  
JGCH Ayurveda Hospital, Ghataprabha, Karnataka 
KLE Ayurveda Hospital, Belagavi, Karnataka 
Parul Ayurved Hospital, Limda, Vadodara, Gujarat 
 
Primary Sponsor  
Name  Dr Jyoti Mallappa Kumbar 
Address  Plot number 69, 9th cross, Gokul Nagar, Post Mutaga, Belagavi, Karnataka 
Type of Sponsor  Other [Individual Research Scholar] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jyoti Mallappa Kumbar  KLE Ayurveda Hospital  KLE Ayurveda Hospital Shahapur
Belgaum
KARNATAKA 
9482628541

drjyotik11@gmail.com 
Dr Jyoti Mallappa Kumbar  Parul Ayurved Hospital  Parul Univeristy campus Limda
Vadodara
GUJARAT 
9482628541

drjyotik11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Ethics committee for research on human subjects  Approved 
Institutional ethical clearance committee-human  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Post-natal patients who have undergone normal vaginal delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CONTROL GROUP  Normal diet and habits, Standard methods of postnatal management 
Intervention  TRIAL GROUP  Ushna jala parisheka, Snehapana with accha ghrita and panchakola churna, Sthanika abhyanga, Udara patta bandhana, Yavagu Pana 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Patients fulfilling diagnostic criteria of Sootika
Patients with full term normal vaginal delivery
Patients with episiotomy wound, perineal tear
 
 
ExclusionCriteria 
Details  Systemic disorders like Diabetes, Tuberculosis etc.
Patients with L.S.C.S.
Conditions like retention of placenta, PPH, IUD, inversion or prolapse of uterus
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Involution of uterus
Abdominal wall circumference
Episiotomy wound healing
 
Involution of uterus
Abdominal wall circumference
Episiotomy wound healing
 
 
Secondary Outcome  
Outcome  TimePoints 
Back ache
Perineal pain
Lactation
After pain
Lochia discharge
Breast engorgement
 
35 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   12/04/2014 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   1. Etiopathogenesis of Female Infertility-Ayurvedline 11th edition(2013) 2. Concept of Udara Patta bandhana (Postpartum abdominal binding)- Phytopharma ISSN: 20/5177/15-17 17th volume, 10th issue 3. Critical analysis of Yavagu- The Antiseptic- ISSN: 003-5998, vol-114, issue-1 4. Sootika Paricharya- A step towards betterment of women’s health- The Antiseptic- ISSN: 003-5998, vol-114, issue-1 5. Role of Bahya snehana in post-natal period- The Antiseptic- ISSN: 003-5998, vol-114, issue-1  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Having a baby is one of the most precious times in a woman’s life. Thankfully, in last few years there has been a change in the attitude about birth from viewing it as a medical emergency to the natural process. This change in the way our culture views birth is so important in creating happy, healthy babies and families, yet there is still a very big missing link: SOOTIKA PARICHARYA / POSTPARTUM CARE.

Ayurveda is not legging behind in recognizing the most prolific facet of woman viz. women is the hub of descendants. Few important of those being the garbhini avastha and sootika avastha which have been clearly recognized and explained in our classics by Acharyas.

Sootika avastha is one such stage where in she should be taken much care as a tot. This sootika avastha can be understood as the puerperium when compared in modern parlance. This period is sometimes referred as fourth trimester, and is the period of reverting back of pelvic organs to non pregnant state in specific. 

The sootika will be weak by nourishing the fetus and also attains shunya shareera due to dhatu kshaya, stress of labor pain, excretion of Kleda and Rakta. Hence the sootika avastha is considered as a critical condition which makes the sootika to go into a very fragile state.

Pregnancy changes women’s body in more ways than they might have guessed, and it doesn’t stop when the baby is born. Until the birth, a healthy baby may be her top priority — but once the baby is born maintaining her fitness, beauty, and self-confidence counts, too. So, all the women of this hi-speed life require special care to be taken in short duration which will make them to feel younger and healthier.Advancement in sciences have made researchers to look back in to the root i.e. Ayurveda. All acharyas have elucidated about Sootika paricharya. The Snehapana, Abhyanga, Parisheka have been described in the conditions like exhaustion, strain, tiredness, back ache etc. These also have their effect on mental wellbeing & helps in recapitulating the healthy status. The unique procedures explained in Sootika Paricharya can bring equilibrium of Kayagni/Dhatwagni which in turn will help for the proper nourishment of dhatus to bring them to the pre-pregnant status. With this view the clinical study entitled “CLINICAL EVALUATION OF THE EFFECT OF CHARAKOKTA SOOTIKA PARICHARYA” is planned.

OBJECTIVE OF THE STUDY

  • Literary review of Sootika, Sootika Paricharya, latest researches related to the Sootika paricharya, Ayurvedic Samhitas, literature related with the allied sciences, journals and internet will be referred.
  • A Conceptual study on Charakokta Sootika Paricharya.
  • To evaluate the efficacy of Charakokta Sootika Paricharya in Sootikas.
  • To compare the effect of Sootika Paricharya in control and trial groups.

Hypothesis

H0: There is no significant effect of ‘Charakokta Sootika Paricharya’ on Sootikas.

H1: The recovery in the symptoms is same in both control and trial groups

H2: There is significant therapeutic effect of ‘Charakokta Sootika Paricharya’ only on the subjective symptoms of Sootika

H3: There is significant therapeutic effect of ‘Charakokta Sootika Paricharya’ only on the Objective signs of Sootika.

H4: There is significant therapeutic effect of ‘Charakokta Sootika Paricharya’ both on Subjective and Objective symptoms of Sootika.

 
Close