| CTRI Number |
CTRI/2025/11/096949 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to find out how effective Laghu Manjisthadi Kwatha sitz bath is in treating piles (Haemorrhoids). |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Evaluate Efficacy of Laghu Manjisthadi 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 Hemangiben Ashokbhai Parmar |
| 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 and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120
Anand
GUJARAT
388120
India |
| Phone |
9773224390 |
| Fax |
|
| Email |
hemangiparmar083@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipsinh B Chavda |
| Designation |
Guide and Head of Dept. of Shalya Tantra |
| Affiliation |
G J Patel Institute of Ayurvedic Studies And Research |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 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 |
Guide and Head of Dept. of Shalya Tantra |
| Affiliation |
G J Patel Institute of Ayurvedic Studies And Research |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 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 and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
|
|
Primary Sponsor
|
| Name |
Dr Hemangiben Ashokbhai Parmar |
| Address |
Department of Shalya Tantra, OPD No. 25, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India- 388120 |
| 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 Hemangiben Ashokbhai Parmar |
S G Patel Ayurvedic Hospital And Maternity Home |
OPD No. 25, Dept. of Shalya Tantra
Anand
GUJARAT |
9773224390
hemangiparmar083@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G J Patel Institute of Ayurvedic Studies and Research, S G Patel Ayurvedic Hospital and Maternity Home Institutional (Human Ethics Committee) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K649||Unspecified hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | avagAhasvedaH, अवगाहस्वेदः | (Procedure Reference: Charak samhita sutrasthana, Procedure details: Sitz bath of Laghu Manjishadii kwath prepared from (Manjistha, Triphala, Vacha, Katuki, Daruharidra, Guduchi) should be advised to seats in the fill tub with Laghumanjisthadi kwatha (50 ml) and warm water 2.5 liters at a tolerable temperature (38-48 degree Celsius) to cover the perianal region.)
(1) Medicine Name: Eranda bhrushta haritaki, Reference: Sushrut samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | avagAhasvedaH, अवगाहस्वेदः | (Procedure Reference: Charak samhita sutrasthana, Procedure details: Fill a tub with warm water (2.5 liter) at a tolerable temperature (38-42 degree celsius) to cover the perianal region. The participant will be made to seat and will be advised to maintain a suitable position for 10 minutes after 10 minutes participants will be advised to clean the area.)
(1) Medicine Name: Eranda bhrushta 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.
2.1st And 2nd Degree Of Arsha. (Haemorrhoids)
3.Irrespective Of Gender, Religion, Occupation & Economic Status.
4.Arsha With 2 Or more than 2 Symptoms As Per Diagnostic Criteria.
|
|
| ExclusionCriteria |
| Details |
1.Age below 18 And above 60 Years Of Both Genders.
2.K/C/O Comorbidity Like DM, HTN, Crohn’s Disease, IBS, Ulcerative Colitis, CA Rectum, Bleeding Disorders, Etc.
3.Diagnosed Cases Of Hbsag, And HIV, Etc.
4.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 |
| Laghu Manjisthadi Kwatha Sitz Bath Will Reduce Pain In Ano, Itching In Ano & Per Rectal Bleeding In The Management Of Arsha (Haemorrhoids). |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Laghu Manjisthadi 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)
|
01/12/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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. Laghu Manjisthadi 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 Eranda Bhrushta 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.
|