CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2026/02/104086 [Registered on: 17/02/2026] Trial Registered Prospectively

Last Modified On:

16/02/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Easy to Use Herbal Tablet Sitz Bath Reduces Pain after Anorectal Surgery

Scientific Title of Study

A Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Panchvalkal Dispersible Tablet As A Substitute To Traditional Panchvalkal Kwath Avagah Sweda For The Symptomatic Relief Of Pain In Post– Operative Anorectal Cases

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 Amit Tarachand Yadav
Designation	PG Scholar
Affiliation	Parul Institute of Ayurved
Address	Department of PG And Ph.D. Studies in Shalya Tantra,Parul Institute of Ayurved,Parul University,P.O.Limda,Taluka Waghodia Vadodara GUJARAT 391760 India
Phone	9594595514
Fax
Email	ay673507@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Parikshit Shirode
Designation	Professor
Affiliation	Parul Institute of Ayurved
Address	Department of PG And Ph.D. Studies in Shalya Tantra,Parul Institute of Ayurved,Parul University,P.O.Limda,Taluka Waghodia Vadodara GUJARAT 391760 India
Phone	9175882746
Fax
Email	parikshit.shirode260038@paruluniversity.com

Details of Contact Person
Public Query

Name	Dr Amit Tarachand Yadav
Designation	PG Scholar
Affiliation	Parul Institute of Ayurved
Address	Department of PG And Ph.D. Studies in Shalya Tantra,Parul Institute of Ayurved,Parul University,P.O.Limda,Taluka Waghodia Vadodara GUJARAT 391760 India
Phone	9594595514
Fax
Email	ay673507@gmail.com

Source of Monetary or Material Support

Parul Institute of Ayurved Parul University P.O. Limda Taluka Waghodia District Vadodara State Gujarat Country India Pin code 391760

Primary Sponsor

Name	Parul Institute of Ayurved
Address	Department of PG And Ph.D. Studies in Shalya Tantra,Parul Institute of Ayurved,Parul University,P.O.Limda,Taluka Waghodia,District Vadodara,Gujarat 391760 India
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 Amit Tarachand Yadav	Parul Institute of Ayurved	OPD and IPD Wards of Department of PG And Ph.D. Studies in Shalya Tantra,Parul Institute of Ayurved,Parul University,P.O.Limda,Taluka Waghodia,District Vadodara,Gujarat 391760 India Vadodara GUJARAT	9594595514 ay673507@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
INSTITUTIONAL ETHICS COMMITTE PARUL INSTITUTE OF AYURVED PARUL UNIVERSITY	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:R52\|\|Pain, unspecified. Ayurveda Condition: SULAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Panchavalkal Dispersible Tablet, Reference: anubhuta, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: To develop a Panchavalkal Dispersible Tablet—a convenient tablet that easily dissolves in warm water to make the same medicated sitz bath instantly.The main goal is to check whether the tablet works as well as or better than the traditional Kwath in reducing post-operative pain and discomfort
2	Comparator Arm	Procedure	-	avagAhasvedaH, अवगाहस्वेदः	(Procedure Reference: Charak Sutrasthan 14/34, Procedure details: Avagah Sweda will be given with the help of Panchvakal Kwath & Patient is advised to sit in lukewarm water mix with Panchvakal Kwath) (1) Medicine Name: Panchvakal Kwath, Reference: Bhavprakash Nighantu Vataadivarga, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 30(g), Frequency: bd, Duration: 7 Days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patient undergone for Anorectal surgeries by Local and Spinal Anaesthesia , who are presenting with post-operative discomfort related to these conditions , irrespective of their Gender, Race, and Occupation . Patients who are above 18 years and below 70 years of age .

ExclusionCriteria

Details

Patients with uncontrolled Diabetes-Mellitus and Hypertension .
Patients not giving consent for enrollment in the study .
Patients having Malignant conditions like Carcinoma of Rectum and Anal Canal

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
1. Reduction in post-operative anorectal pain (VAS score). 2. Faster pain relief compared to traditional Panchavalkal Kwatha Avagah Sweda.	7 Days

Secondary Outcome

Outcome	TimePoints
1. Decrease in burning sensation, swelling, tenderness, and itching. 2. Reduced recurrence of pain during follow-up. 3. Improved patient comfort and treatment compliance.	7 Days

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

Date of First Enrollment (India)

02/03/2026

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

After anorectal surgeries like piles (hemorrhoids), fissure, or fistula operations, patients commonly experience pain, burning, swelling, and discomfort around the anal region. Managing this pain is very important because it affects daily activities, sleep, and overall recovery. In Ayurveda, one effective method for reducing such pain is Avagaha Sweda, also known as a medicated sitz bath. Traditionally, this procedure uses Panchavalkal Kwath, a herbal decoction made by boiling the bark of five specific trees. This mixture has natural pain-relieving, wound-healing, and anti-inflammatory properties. However, preparing this Kwath takes a lot of time, effort. Patients today often have busy schedules, limited resources, and less patience to prepare such decoctions twice a day. To solve this problem, this study aims to develop a Panchavalkal Dispersible Tablet—a convenient tablet that easily dissolves in warm water to make the same medicated sitz bath instantly. This saves time, avoids the need for boiling, ensures accurate dosage, prevents contamination, and is easier to carry and use at home. The research will involve 40 patients who have undergone anorectal surgery. They will be divided into two groups: Group A: Will use the new Panchavalkal Dispersible Tablet for sitz bath. Group B: Will use the traditional Panchavalkal Kwath. Both groups will follow the treatment for 7 days, and their pain, swelling, burning, itching, and tenderness will be regularly measured using simple scoring systems like the Visual Analogue Scale (VAS). The main goal is to check whether the tablet works as well as or better than the traditional Kwath in reducing post-operative pain and discomfort. If successful, this innovation can make post-surgery care much easier and more effective for patients, improving recovery and comfort while reducing time and effort.