| CTRI Number |
CTRI/2025/07/091300 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
20/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Standardization of Ayurvedic protocols said during postnatal period in patients. |
|
Scientific Title of Study
|
Randomised control trial(RCT) of sutika paricharya to validate the standard procedures of sutika paricharya |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahi Pravesh Mishra |
| Designation |
Professor |
| Affiliation |
Government Ayurveda College |
| Address |
Government Ayurveda College Amkho Gwalior
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9826239560 |
| Fax |
|
| Email |
drmahimishra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Gokarn |
| Designation |
Dean Professor |
| Affiliation |
Swaminarayan Ayurveda College |
| Address |
Swaminarayan Ayurveda College Swaminarayan University Campus Ahmedabad Mehsana Gandhinagar
Gandhinagar
GUJARAT
382725
India |
| Phone |
9449231730 |
| Fax |
|
| Email |
ssackalol@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rohit Gokarn |
| Designation |
Dean professor |
| Affiliation |
Swaminarayan Ayurveda College |
| Address |
Swaminarayan Ayurveda College Swaminarayan University Campus Ahmedabad Mehsana Highway Gandhinagar
Gandhinagar
GUJARAT
382725
India |
| Phone |
9449231730 |
| Fax |
|
| Email |
ssackalol@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College Amkho Gwalior |
|
|
Primary Sponsor
|
| Name |
Dr Mahi Pravesh Mishra |
| Address |
Professor Prasuti Tantra and Stri Roga Department Government Ayurveda College Amkho Gwalior 474009 |
| Type of Sponsor |
Other [Self] |
|
|
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 mahi pravesh mishra |
Government Ayurveda College |
Department of Stri prusuti Government Ayurveda College Gwalior
Gwalior
MADHYA PRADESH |
09826239560
drmahimishra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INstituitional Ethical Committee, Swaminarayan University, Kalol |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O90||Complications of the puerperium, not elsewhere classified. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: We design a 45 days regimen asper the Ayurveda classics for the puerperal women which includes Abhyanga (massage by trained female with medicated oils depending on the Prakruti of the woman and the seasonal changes), Swedan
(Medicated steam from the medicated decoction), Dhoopan (smoke of the mediated herbs at the perineal area which is done with the help of specially designed Dhoopan chair), Kwatha Paan (decoction to drink made up of Vatahar Drayva’s (drugs that reduce Vata Dosha), Parishek (bathing with medicated water), Udaraveshtana (a clean cotton cloth to be tied on the abdomen), proper dietetics advise depending on the patient’s routine and type of food they consume. Yoga (post-natal yoga exercises)., Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | | Normal routine |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Who has uneventful vaginal delivery who screens negative for viral infections like hiv vdrl hbsag |
|
| ExclusionCriteria |
| Details |
Woman who has delivered abdominally. Who has eventful delivery eclampsia, pre eclampsia, gestational diabetes. Women with chronic diseases like thyroid dysfunction, asthma, epilepsy, cvs, renal or biliary diseases. Woman with compromised mental health. Women with congenital chromosomal or skeletal defects. Who is severely anaemic. Who is under medication foe any mental illness. Women with already existing genital prolapse. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To standardize the post natal procedures mentioned in our brihatrayis to standardize the duration of the procedure to standardize the oils, medicines and dietetics to be followed during sutika paricharya. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 1 |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
These days the lifestyle and responsibilities of women have also changed incredibly over the last few decades. Juggling between personal and professional responsibilities often results into intensified stress and compromised mental health. As there are different schools of thought regarding sutika paricharya the gap has to be minimized and a standard technique has to be practiced to benefit the population. After delivery the woman should follow abhyanga, swedana and other modalities. This practice differs as per the geographical region, consideration pf climacteric changes as well as family background. Madhya Pradesh being jangala desh where predominance of vata, pitta dosha is seen, sneha becomes satmya in this region hence a regimen which benefits the post natal woman and helps them give the better health care is of utmost necessity. Also a detailed study needs to be carried out to understand the differences on the basis of various physical and mental parameters to know and record the usefulness of sutika paricharya so as to make it more acceptable towards population. The diets and regimen described by our acharyas in ayurvedic literature regarding sutika is completely scientific and acceptable. Standard operating procedures with proper guidance of ahar, vihar, achara for the purpose of punarnaveekaran itself is sutika paricharya. |