| 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
|
|
|
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
|
|
|
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. |