CTRI

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CTRI Number

CTRI/2026/01/101279 [Registered on: 15/01/2026] Trial Registered Prospectively

Last Modified On:

19/01/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Clinical Trial between Bhadrotkatadya Avaleha and Panchakola Churna in sutika shool.

Scientific Title of Study

A randomized open labelled comparative clinical study to evaluate the efficacy of bhadrotkatadya avaleha and panchakola churna in the management of sutika sula

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 Vaibhavi Shripati
Designation	PG Scholar
Affiliation	Shree Swaminarayan Ayurvedic college and hospital Kalol
Address	Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic college and hospital Kalol Shree Swaminarayan Ayurvedic college and hospital Kalol Gandhinagar Gandhinagar GUJARAT 382725 India
Phone	9033650820
Fax
Email	shivanishripati@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Ranjana Ingale
Designation	HOD & Prof PTSR Dept
Affiliation	Shree Swaminarayan Ayurvedic College and Hospital Kalol
Address	Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic College and Hospital Kalol Shree Swaminarayan Ayurvedic College and Hospital Kalol Gandhinagar Gandhinagar GUJARAT 382725 India
Phone	9909945110
Fax
Email	ranjanaingale7396@gmail.com

Details of Contact Person
Public Query

Name	Dr Vaibhavi Shripati
Designation	PG Scholar
Affiliation	Shree Swaminarayan Ayurvedic college and hospital Kalol
Address	Department of Prasuti Tantra evum Stree Roga Shree Swaminarayan Ayurvedic college and hospital Kalol Shree Swaminarayan Ayurvedic college and hospital Kalol Gandhinagar Gandhinagar GUJARAT 382725 India
Phone	9033650820
Fax
Email	shivanishripati@gmail.com

Source of Monetary or Material Support

Shree Swaminarayan Ayurvedic College and Hospital Ahmedabad Mehsana Highway AT PO Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT

Primary Sponsor

Name	Shree Swaminarayan Ayurvedic College, Kalol
Address	Faculty of Ayurved Shree Swaminarayan Ayurvedic College Ahmedabad Mehsana Highway AT PO Saij Ta Kalol Dist Gandhinagar 3GUJARAT India
Type of Sponsor	Private medical college

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 Vaibhavi Shripati	Premswarup Swami Ayurvedic Multispecialty Hospital	OPD 001 Department of Prasuti Tantra Evum Stree Roga Premswarup Swami Ayurvedic Multispeciality Hospital Ahmedabad-Mehsana Highway At Po Saij Ta Kalol Dist Gandhinagar 382725 GUJARAT Gandhinagar GUJARAT Gandhinagar GUJARAT	9033650820 shivanishripati@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 1
Name of Committee	Approval Status
SWAMINARAYAN UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH	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. Ayurveda Condition: SUTIKAROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Bhadrotkatadya Avaleha , Reference: Bhaisajya Ratnavali chapter 69 sutika rogaadhikar shloka 21 to 24, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -warm milk), Additional Information: -
2	Comparator Arm	Drug	Classical		(1) Medicine Name: panchkola churna, Reference: Ashtang Hridaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -

Inclusion Criteria

Age From	18.00 Day(s)
Age To	40.00 Day(s)
Gender	Female
Details	1.Women aged 18–40 years who have delivered within 7 days (vaginal delivery primi & multi) 2.Presenting with symptoms as per diagnostic criteria 3.Willing to participate and comply with follow-up for 60 days 4.Capable of providing written informed consent

ExclusionCriteria

Details

1.Age below 18 years or above 40 years
2.Cesarean delivery, instrumental delivery, or manual removal of placenta
3.Spinal conditions Pott’s spine (TB spine),Spinal cord compression,History of trauma or surgery to spine/lower back
4.Rheumatoid arthritis, ankylosing spondylitis, or other systemic musculoskeletal disorders
5.Severe anemia (Hb less than 8gm percent) or postpartum hemorrhage (PPH)
6.Back pain due to structural disc prolapse, vertebral fracture, or known neurological condition
7.Patients with uncontrolled diabetes

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Significant reduction in Sutika sula as assessed by. Visual Analogue Scale (VAS)	Baseline day 30

Secondary Outcome

Outcome	TimePoints
Improvement in associated symptoms such as Adhmana Agnimandya Regularization of mala and mutra vegas improved subjective feeling of comfort, and well being during postpartum recovery High Tolerability and compliance to Bhadrotkatadya Avaleha without significant adverse effect during and after treatment	Baseline day 30

Target Sample Size

Total Sample Size="40"
Sample Size from India="40"
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/ Phase 3

Date of First Enrollment (India)

27/01/2026

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="0"
Months="3"
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

Sutika sula, particularly postpartum back pain (prstha Kati Sula), is a common condition in the puerperal period caused by Vata aggravation and tissue depletion, which affects mobility, sleep, and breastfeeding comfort, while modern management focuses mainly on analgesics and antibiotics, it does not address digestive weakness or systemic nourishment, creating a clinical evidence gap in Ayurveda regarding formulation based comparative pain management in lactating mothers, so this randomized open label parallel arm study will evaluate 40 postpartum women delivered vaginally within 7 days, comparing Bhadrotkatadya Avaleha (12 g BID with warm milk) and Panchakola Churna (6 g BID with warm water) for 60 days, using standardized pain assessment through VAS and a modified symptom score based on the Brief Pain Inventory framework, along with evaluation of associated symptoms like abdominal distension, constipation, appetite, formulation compliance, palatability, and safety monitoring for both mother and infant, with anticipated outcomes of significant pain reduction and better postpartum recovery, contributing to evidence based Ayurvedic postpartum care protocols.