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CTRI Number  CTRI/2024/08/072400 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Panchavalkala Kwatha Sitz Bath In the Management Of Arsha. 
Scientific Title of Study   A Randomized Controlled Clinical Study To Evaluate Efficacy Of Panchavalkala Kwatha Sitz Bath In The Management Of Arsha (Haemorrhoids). 
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 Prashant Ramachandra Madane 
Designation  PG Scholar 
Affiliation  G.J. Patel Institute Of Ayurvedic Studies And Research. 
Address  Department Of Shalya Tantra, OPD No-25, S. G. Patel Ayurveda Hospital & Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat- 388120

Anand
GUJARAT
388120
India 
Phone  7028325904  
Fax    
Email  madanepr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipsinh B Chavda  
Designation  HOD And Professor 
Affiliation  G.J. Patel Institute Of Ayurvedic Studies And Research. 
Address  Department Of Shalya Tantra, OPD No-25, S. G. Patel Ayurveda Hospital & Maternity Home, New Vallabh Vidya Nagar, Anand, Gujarat- 388120

Anand
GUJARAT
388120
India 
Phone  9428491219  
Fax    
Email  dispinh.chavda@cvmu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Dipsinh B Chavda  
Designation  HOD And Professor 
Affiliation  G.J. Patel Institute Of Ayurvedic Studies And Research. 
Address  Department Of Shalya Tantra, OPD No-25, S. G. Patel Ayurveda Hospital & Maternity Home, New Vallabh Vidya Nagar, Anand, Gujarat- 388120

Anand
GUJARAT
388120
India 
Phone  9428491219  
Fax    
Email  dispinh.chavda@cvmu.edu.in  
 
Source of Monetary or Material Support  
S. G. Patel Ayurveda Hospital & Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India - 388120 
 
Primary Sponsor  
Name  Dr Prashant Ramachandra Madane 
Address  Department Of Shalya Tantra, OPD No-25, S. G. Patel Ayurveda Hospital & Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat- 388120 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NILL  NILL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prashant Ramachandra Madane  S. G. Patel Ayurveda Hospital And Maternity Home  Department of Shalya Tantra, Room No. 25, New Vallabh Vidyanagar, Anand, Gujarat, India - 388120
Anand
GUJARAT 		 7028325904

madanepr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional(Human) Ethics Committtee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-avagAhasvedaH, अवगाहस्वेदः (Procedure Reference: Sushruta Samhita, Procedure details: Sitz Bath of panchavalkala Kwatha prepared from Nyagrodha, Udumbar, Ashvatha, Parisha, Palksha. should be advised to seats in the fill tub with panchavalkala Kwatha (50 ml) and Warm Water (2.5 liters) at a tolerable temp. (38 - 42 degree Celsius) to cover the perineal region.)
(1) Medicine Name: Erandbhrushta Haritaki, Reference: Sushruta Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Duration: 7 Days
2Comparator ArmProcedure-avagAhasvedaH, अवगाहस्वेदः (Procedure Reference: Sushruta Samhita, Procedure details: •Fill a tub with Warm Water (2.5 Lit) at a tolerable temperature {38 - 420c}). to cover the perianal region. • The participant will be made to sit and will be advised to maintain a suitable position for 10 minutes • After 10 min Participants will be advised to clean the area.)
(1) Medicine Name: Erandbhrushta Haritaki, Reference: Sushruta Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age group of 18 to 60 years.
2. Irrespective of gender, religion, occupation & economic status.
3. Classical symptoms of Arsha with 2 or more than 2 symptoms as per diagnostic criteria.
 
 
ExclusionCriteria 
Details  1. K/C/O Comorbidity like DM, HTN, Chron’s disease, IBS, ulcerative colitis, CA rectum,
Bleeding disorders, etc.
2. Diagnosed cases of HBsAg, and HIV, etc.
3. Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Panchavalkala Kwatha sitz bath will reduce pain in ano, itching in ano & rectal bleeding in the management of Arsha (Haemorrhoids).  7 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Panchavalkala Kwatha sitz bath will help to reduce the Swelling of pile mass.  7 Days 
 
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 3/ Phase 4 
Date of First Enrollment (India)   10/10/2024 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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   In randomized controlled clinical study 30 participants will be selected and equally divided into both groups. panchvalkala kwatha sitz bath will given to trial group and warm water will be given to the control group for 10 min twice a day for 28 days along with erandabhrushta haritaki powder 5gm Hs with milk/water in both group. follow up will be done on every 7th day. assessment will be done with case record form with criteria like per rectal bleeding, itching in ano, gudavedana and degree of piles.collected data will analyzed statistically by using a suitable method, and conclusion will be drawn. 
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