| CTRI Number |
CTRI/2025/06/089668 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study conducted to test how well Pathyadi Churna works in treating Kaphaj Atisara |
|
Scientific Title of Study
|
An open randomized controlled clinical trial to evaluate the efficacy of Pathyadi churna in the management of Kaphaja Atisara with special reference to Diarrhoea |
| 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 Shweta Vishwanath Suryawanshi |
| Designation |
PG scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Kayachikitsa Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Kayachikitsa Department Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9067523527 |
| Fax |
|
| Email |
shwetasuryawanshi757@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Viraj Vinayak Shukla |
| Designation |
Professor |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Kayachikitsa Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Kayachikitsa Department Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9822936193 |
| Fax |
|
| Email |
rajvishukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Viraj Vinayak Shukla |
| Designation |
Professor |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalaya Kayachikitsa Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya Kayachikitsa Department Gadhinglaj Kolhapur pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9822936193 |
| Fax |
|
| Email |
rajvishukla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patients Late Kedari Redekar Ayurvedic Mahavidyalaya Room no. 1 kayachikitsa OPD Gadhinglaj kolhapur India
pin 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Shweta Vishwanath Suryawanshi |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalaya room no.1 kayachikitsa OPD Gadhinglaj kolhapur India
Pin 416502 |
| 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 Shweta Vishwanath Suryawanshi |
Late Kedari Redekar dharmaday rugnalaya Gadhinglaj,kolhapur |
OPD no 1 and IPD of kayachikitsa department,Late Kedari Redekar Ayurvedic hospital,Gadhinglaj Kolhapur pin 416502.
Kolhapur
MAHARASHTRA |
9067523527
shwetasuryawanshi757@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi churna , Reference: Bharat Bhaishajya Ratnakar Part 3 shlok no. 3897, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Gangadgar Churna , Reference: Bhavprakash Samhita Madhyam Khand Dwitiya Atisara Adhikar Adhyay 2 shlok no. 31, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Takra and Gud), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)The patient with classical signs and symptoms of kaphaj atisara will be selected having age between 20 years to 60 years
2)The patient having following mala rupa
Sweth purish
Snigdha purish
Picchila purish
Tantumaya purish
Aamyukta purish
Guru purish
3) Patients from all socio economic status. |
|
| ExclusionCriteria |
| Details |
1)Patients with severe dehydration and more than 8 diarrheal episodes
2)Patients with chronic disorders such as DM, malignant HTN,HIV,Carcinoma of colon,Intestinal tuberculosis and Gudabhransha.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PATHYADI CHURNA IS EFFECTIVE IN THE MANAGEMENT OF KAPHAJ ATISARA |
Initial assessment at 0 day
Follow up at 3rd and 7th day
Final assessment at 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PATHYADI CHURNA IS MORE EFFECTIVE THAN GANGADHAR CHURNA IN THE MANAGEMENT OF KAPHAJ ATISARA |
Initial assessment at 0 day
Follow up at 3rd and 7th day
Final assessment at 15th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/07/2025 |
| 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 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
|
This study is an open randomized controlled clinical trial to evaluate the efficacy of Pathyadi churna in the management of Kaphaj atisara w.s.r. to diarrhoea. study will be carried at OPD of kayachikitsa department of Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital Gadhinglaj. The observation would be drawn on the basis of symptoms after treatment is given |