| CTRI Number |
CTRI/2025/06/089703 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| 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
|
To compare the pain managing property in Piles of Patha Churn and Yawani Churna (Herbal Remedies) with tab.diclofenac sodium and serratopeptidase (Painkiller Tablets) |
|
Scientific Title of Study
|
RANDOMISED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF PATHA CHURN WITH YAWANI CHURN COMPARED TO TABLET DICLOFENAC SODIUM (50 mg ) AND SERRATIOPEPTIDASE (10 mg ) IN THE PAIN MANAGEMENT OF SHUSHKARSH |
| 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 Sushmita Chavan |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Department of Shalyatantra 2nd floor Tilak Ayurved Mahavidyalaya Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8329923642 |
| Fax |
|
| Email |
sushchavan10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipak Poman |
| Designation |
Associate professor department of Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Department of Shalyatantra 2nd floor Tilak Ayurved Mahavidyalaya Rasta Peth Pune
Department of Shalyatantra 2nd floor Tilak Ayurved Mahavidyalaya Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8308612087 |
| Fax |
|
| Email |
dipakpoman@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSushmita Chavan |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya and Seth Tarachand Ramnath Charitable Ayurvedic Hospital |
| Address |
Department of Shalyatantra 2nd floor Tilak Ayurved Mahavidyalaya Rasta Peth Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
08329923642 |
| Fax |
|
| Email |
sushchavan10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital Rasta Peth Pune Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Rasta Peth Pune-411011, Maharashtra,India |
| Type of Sponsor |
Private 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 Sushmita Chavan |
Seth Tarachand Ramnath Charitable Ayurvedic Hospital Pune |
Department of Shalyatantra OPD 7 ground floor Rasta Peth Pune
Pune
MAHARASHTRA |
08329923642
sushchavan10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee TAMV, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Patha Churn with Yawani Churn , Reference: Charak chikista 14/100, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -koshn jal), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Diclofenac sodium+ serratiopeptidase, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants having classical symptom of shushkarsha(pain,hard stool,constipation) will be taken as subject to study
Participants of 1 and 2 nd degree piles
Participants of age between 20-60 years were taken
Selection of participants will be irrespective of sex, socio -economic class, religion |
|
| ExclusionCriteria |
| Details |
Participants suffering from Shushkarsha associated with following disease will be excluded
Known case of
bleeding disorder
Ulcerative collitis
Ca rectum
3rd and 4th degree haemorrhoid
Pregnancy
Participants below 20 and above 60 years are excluded |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mild relief in pain of arsh
Mild decrease in constipation |
3rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decrease in pain of arsha
No constipation |
7th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/07/2025 |
| 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) |
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
|
The study will be intervened by the treatment of Patha Churna with Yawani Churna and Tablet Diclofenac sodium (50mg) and serratopeptidase (10mg) to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis, scoring will be designed according to severity of symptoms, the subjective gradation of symptoms will be done as follows and intensity of each symptoms will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on basis of grading and scoring system. The signs and symptoms will be assessed by adopting suitable scoring method. |