| CTRI Number |
CTRI/2025/03/082630 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| 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 study to check how well Rasanjanadi Churna works in treating diarrhea.
|
|
Scientific Title of Study
|
A randomized open contolled clinical trial to assess the efficacy of Rasanjanadi Churna in The management of kaphaj 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 Omprakash Manohar Didpaye |
| Designation |
PG Scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidyalay Kayachikitsa Department Gadhinglaj Kolhapur pin 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalay room no. 1 kayachikitsa department Gadhinglaj Kolhapur India pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
7972314381 |
| Fax |
|
| Email |
odidpaye@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vibhavari Tukaram Kokane |
| Designation |
Professor at Kayachikitsa department |
| Affiliation |
LATE KEDARI REDEKAR AYURVEDIC MAHAVIDYALA ,GADHINGLAJ KOLHAPUR |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalay room no. 1 kayachikitsa department Gadhinglaj Kolhapur India pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420326846 |
| Fax |
|
| Email |
vibhavari.kokane@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vibhavari Tukaram Kokane |
| Designation |
Professor at Kayachikitsa department |
| Affiliation |
LATE KEDARI REDEKAR AYURVEDIC MAHAVIDYALA ,GADHINGLAJ KOLHAPUR |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalay room no. 1 kayachikitsa department Gadhinglaj Kolhapur India pin 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9420326846 |
| Fax |
|
| Email |
vibhavari.kokane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patients at Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhinglaj Kolhapur India pin code 416502 |
|
|
Primary Sponsor
|
| Name |
Dr Ompraksh Manohar Didpaye |
| Address |
Late Kedari Redekar Ayurvedic Mahavidyalay room no. 1 kayachikitsa OPD Gadhinglaj Kolhapur India pin 416502 |
| Type of Sponsor |
Other [] |
|
|
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 Omprakash Manohar Didpaye |
Late Kedari Redekar dharmaday rugnalaya, room no. 1 kayachikitsa department,Gadhinglaj,Kolhapur |
Late Kedari Redekar Ayurvedic Mahavidyalay room no. 1 kayachikitsa department Gadhinglaj Kolhapur India pin 416502
Kolhapur
MAHARASHTRA |
7972314381
odidpaye@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Late Kedari Redekar Ayurvedic Mahavidyalaya Gadhjinglaj, Kolhapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K31||Other diseases of stomach and duodenum. Ayurveda Condition: ATISARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: RASANJANADI CHURNA, Reference: CHARAK SAMHITA CHIKITSA STHAN 19/108, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: MADHU AND SHUNTHI), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: GANGADHAR CHURNA, Reference: BHAVPRAKASH ATISAR ADHYAY 2/31, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, 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 |
PATIENTS HAVING TEXTUAL SIGNS AND SYMPTOMS OF KAPHAJ ATISAR |
|
| ExclusionCriteria |
| Details |
1. Diabetes mellitus, hypertension,HIV, Carcinoma
2. patients with severe dehydration and more than 8 diarrheal episodes
3. Raktaatisara, visuchika(cholera),Pravahika |
|
|
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 |
| Rasanjanadi Churna is effective in the management of Kaphaj Atisara |
Initial assessment at day 0
Follow up at 3rd,7th and 15th day
Final assessment at 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rasanjanadi Churna is effective in the management of Atisara than Gangadhar churna |
Initial assessment at day 0
Follow up at 3rd,7th and 15th 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)
|
31/03/2025 |
| 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
|
The study is randomized open contolled clinical trial to assess the efficacy of Rasanjanadi Churna in The management of Atisara with special reference diarrhoea. Study will be carried out 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. |