FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/05/025422 [Registered on: 28/05/2020] Trial Registered Prospectively
Last Modified On: 13/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   A clinical study on the role of Ayurvedic regimen in prasuta 
Scientific Title of Study   A clinical study on the role of charakokta regimen in sutika paricharya ; proof of concept 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 Komal Gurjar 
Designation  PG Scholar 
Affiliation  national institute of ayurveda jaipur  
Address  Department of prasuti and stri roga national institute of ayurveda jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  8952993305  
Fax    
Email  gurjarkomal427@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr B Pushpalatha 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda 
Address  Department of prasuti and stri roga national institute of ayurveda jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9413206790  
Fax    
Email  pushpalathania@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr B Pushpalatha 
Designation  Associate Professor 
Affiliation  National Institute of Ayurveda 
Address  Department of prasuti and stri roga national institute of ayurveda jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9413206790  
Fax    
Email  pushpalathania@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Near Jorawar singh gate amer road jaipur Pin Code 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jorawar singh gate amer road jaipur 
Address  National Institute of Ayurveda Near Jorawar singh gate amer road jaipur 302002 rajasthan  
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 Komal Gurjar  National Institute of Ayurveda  Deptartment of Prasuti tantra avum stri roga national Institute of Ayurveda Near jorawar Singh gate amer road jaipur Pin Code 302002
Jaipur
RAJASTHAN 
8952993305

gurjarkomal427@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O909||Complication of the puerperium, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Pippalyadi Churna (Pippali,Pippalimoola,Chavya ,Sudha Chitrak , Nagar)( 2. Tila taila 3. Goghrita 4. Vidarikanda churna   1 Dose of Pippalyadi churna : 3 gm 2 Dose of tila taila : 30 ml 3 Dose of Goghrita : 20ml 4. Dose of vidarikanda churna : 4gm 5 Route of Churna : oral 6 route of tila taila : local application 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1. Primipara/multipara with noncomplicated full term vaginal delivery,
2. Age between 20 – 35 years
3. Patient willing and able to participate in the study.
4. Women delivered with Muladhar chedan (episiotomy)
5. Women delivered with Muladhar bhedan (perineal tear)
 
 
ExclusionCriteria 
Details  1. Woman who delivered by Caesarian section or forceps delivery/ vacuum application
2. Puerperium associated with complications like severe postpartum haemorrhage, acute inversion of uterus, puerperal eclampsia, psychosis, postnatal diabetes.
3. Women with evidence of malignancy.
4. Women having any systemic disorder.
5. Women having any infection during pregnancy.
6. Women on prolonged (> 6 weeks) medication with corticosteroids, antidepressants, anticholinergics, etc. or any other drugs that may have an influence on the outcome of the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of charakokta sutika paricharya in well being of sutika   15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To provide more effective, safe and side-effect free management of Sutika .   15days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 2 
Date of First Enrollment (India)   01/06/2020 
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="0"
Months="0"
Days="15" 
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)?  

Brief Summary  

A postnatal period begins immediately after the separation of placenta and extending up to six weeks (this period varies as some Acharyas described up to 45days or up to 6 months after delivery)[1],otherwise called as puerperium or puerperal period. The care given during this period is called as Sutika Paricharya in Ayurveda. During the time of labour mother undergoes tremendous physical exertion and becomes extremely debilitated physically and mentally; which leads to derangement of Doshas especially Vata dosha in the mother. These pathological changes cause general weakness, pain abdomen, low back pain, loss of appetite, dysfunction of bladder, post-natal psychosis etc. Apart from these, mother also suffers with Dhatukshya. If this stage is unattended by appropriate measures then that will lead to maternal morbidity.

            In order to reduce the postpartum maternal morbidity, reforming postpartum care measures by providing holistic and flexible maternal health care is necessary. The WHO suggested that maternal care should be de-medicalized, individualized, family-centered, multidisciplinary, holistic, and culturally appropriated.

         In the existing modern medical system, puerperal care limits to supplementation of the iron, calcium and prevention of infections. Two major demands of Puerperium i.e. care for proper involution of genital organs and ensuring optimum lactation are still left un-addressed. Whereas in Ayurveda medicaments and procedures described for post-natal woman is culturally very much appropriate, is by and large comprehensive in serving all the demands of the pueperium. It is by far more scientific and helps in proper involution of the uterus, ensures optimum lactation, kindles digestive as well as metabolic fire, replenishes the lost Dhatu (tissue elements), prevents infections, helps to regain tone of urinary bladder and other smooth muscle organs like intestine,finally it ensures the uneventfull pueperium and complete growth of the body



[1] Kaviraj Atridev Gupt, Sushrut sharira sthana 10/18, Chaukhambha Sanskrit Prakashan, Varanasi

 

 

 
Close