| CTRI Number |
CTRI/2026/04/109655 [Registered on: 28/04/2026] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Ayurvedic medicines and procedures on Recovery After Delivery : An Exploratory Study |
|
Scientific Title of Study
|
EFFICACY OF AYURVEDIC REGIMEN IN ENHANCING POSTPARTUM RECOVERY: AN EXPLORATORY STUDY |
| 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 MEETA JHALA |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Striroga Evam Prasuti Tantra Room no 411 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi
Department of Striroga Evam Prasuti Tantra Room no 412 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
08107415431 |
| Fax |
|
| Email |
meetajiten6978@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MEETA JHALA |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Striroga Evam Prasuti Tantra Room no 411 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi
Department of Striroga Evam Prasuti Tantra Room no 412 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
08107415431 |
| Fax |
|
| Email |
meetajiten6978@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MEETA JHALA |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department of Striroga Evam Prasuti Tantra Room no 411 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi
Department of Striroga Evam Prasuti Tantra Room no 412 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi
South
DELHI
110076
India |
| Phone |
08107415431 |
| Fax |
|
| Email |
meetajiten6978@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
Mathura road Gautampuri Sarita Vihar Delhi 110076 |
| Type of Sponsor |
Government medical college |
|
|
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 Meeta Jhala |
All Inda Institute ofAyurveda, New Delhi |
ROOM NO 411 Fourth floor academic block C Block SRPT Department All Inda Institute of Ayurveda Gautampuri New Delhi
South
DELHI |
8107415431
meetajiten6978@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIA INTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z392||Encounter for routine postpartum follow-up. Ayurveda Condition: SUTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saubhagyashunthi Paka , Reference: Bhaishajya Ratnavali 76/179-182, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: 200 ml milk), Additional Information: -Along with Saubhagyashunthi Paka, Devadarvyadi kwatha (Reference: Sharanghdhar Samhita Madhyam Khanda 47-49) 20 ml BD will be administered to the participants . During the intervention period, Sutika Pathyahara will be administered orally for a duration of six weeks. In addition to oral medications, the participants will receive Abhyanga with Bala Taila for five days, Udara Pattabandhana for two weeks, and Yoni Dhoopana (vaginal fumigation) for five days. This classical post-partum care regimen, as described in the Charaka Samhita, Sushruta Samhita and Kashaypa Samhita will be adopted and implemented as part of the trial protocol. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primipara or multipara with non complicated full term delivery
Women of reproductive age group 20-35years
Women in 1st or 2nd of postnatal day
Patients willing for trial will be selected
|
|
| ExclusionCriteria |
| Details |
Women who delivered by c section or vaccum or forceps delivery
Women of age greater than 35 years or less than 20 years
Puerperium associated with complications like severe PPH or acute inversion of uterus and puerperal eclampsia
Puerperium with uncontrolled diabetes mellitus HbA1C more than 8%
Puerperium with active herpes on having history of HIV1&2 HbsAg TB Chronic medical condition
Participants have a major systemic illness like DM Hypertension
Active genital tract infection
CA of the genital tract
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical effectiveness of Ayurvedic protocol to assess early involution of the uterus in postnatal mother |
at 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Enhancement of the postnatal recovery outcomes Efficacy in Lactation – measured through parameters such as onset of lactation, quantity and quality of breast milk, and infant weight gain trends.
Improvement in Associated Postnatal Symptoms – assessment of relief in backache, abdominal pain, fatigue, oedema, anorexia, sleep disturbances, bowel irregularities, and depression using validated scoring tools.
Prevention of puerpueral infection.
Episiotomy Wound Healing – evaluation based on wound healing scores and time taken for complete healing.
Quality of Life of Postnatal Mother – measured using validated postpartum quality of life assessment tools to determine the overall physical, psychological, and social well-being after Ayurvedic protocol intervention.
|
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
01/06/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is designed to assses the clinical efficacy of ayurvedic formulations like Saubhagyashunthi paka, Devadarvyadi kashaya, Sutika diet regimen, mridu abhyanga, Yonidhoopan and udar pattabandhana in promoting recovery in post natal woman over an 6 week period. Early uterine involution is primary objective and efficacy on lactation, effect on associated symptoms backache, pain in abdomen, fatigue, oedema, anorexia, sleep disturbances and depression, effect on episiotomy wound healing, impact on quality of life, safety, tolerability, sustainability are the secondary objectives. total Study duration will be 10 weeks and 6 visits for each subject. Study will be conducted on Postpartum patrient attending the IPD of SRPT,AIIA,New Delhi. All the subjective objectives and lab parameters will be summarised as mean, standard deviation, median and IQR according to their data type. all the analysis will be done using IBM SPSS statistics and for both ITT and protocol. |