| CTRI Number |
CTRI/2025/04/085499 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The study asses how effective bhringraj yog is in managing urdhwaga amlapitta which corresponds to gastroesophageal reflux disease. |
|
Scientific Title of Study
|
A study to evaluate the efficacy of Bhringraj yog in the management of Urdhwag amlapitta an open randomised controlled clinical trial W.S.R. to Gastroesophageal Reflux Disease |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
drAjay vasanta marge |
| Designation |
Pg scholar |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidylaya, Gadhinglaj, Kolhapur. 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidylaya Room no. 1 Kayachikitsa Department, Gadhinglaj, Kolhapur, India pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8605207909 |
| Fax |
|
| Email |
dr.ajaymarge@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Satgonda B patil |
| Designation |
Reader |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidylaya, Gadhinglaj, Kolhapur. 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidylaya Room no. 1 Kayachikitsa Department, Gadhinglaj, Kolhapur, India pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8600660485 |
| Fax |
|
| Email |
dr.jayantpatil07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Satgonda B Patil |
| Designation |
Reader |
| Affiliation |
Late Kedari Redekar Ayurvedic Mahavidylaya, Gadhinglaj, Kolhapur. 416502 |
| Address |
Late Kedari Redekar Ayurvedic Mahavidylaya Room no. 1 Kayachikitsa Department, Gadhinglaj, Kolhapur, India pin code 416502
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
8600660485 |
| Fax |
|
| Email |
dr.jayantpatil07@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 Ajay Vasanta Marge |
| Address |
Late Kedari Redekar Ayurvedic Mahavidylaya Room no. 1 Kayachikitsa Department, Gadhinglaj, Kolhapur, India pin code 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 |
| DrAjay vasanta marge |
Late Kedari Redekar Dharmadaa rugnalaya gadhinglaj, kolhapur |
Late Kedari Redekar Ayurvedic Mahavidylaya Room no. 1 Kayachikitsa Department, Gadhinglaj, Kolhapur, India pin code 416502
Kolhapur
MAHARASHTRA |
8605207909
dr.ajaymarge@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:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhringraj yog , Reference: Bhaishajya ratnavali , Route: Oral, Dosage Form: Varti/ Suppository, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avipattikar churn vati , Reference: Bhaishjya ratnavali, Route: Oral, Dosage Form: Varti/ Suppository, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshnajal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient having symptoms of Urdhwag Amlapitta like tikta
Amloudgar, aruchi , Shirshul, Hritkanth daha, Chardi
|
|
| ExclusionCriteria |
| Details |
1. Patient below 16 yrs and above 60 yrs will be excluded
2. Pregnant and lactating women. 3. Patient having chronic diseases like Diabetis mellitus with
complication, and chronic kidney diseases, Alcoholic liver
Cirrhosis, Hypertension. |
|
|
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 |
| Bhringraj yog is effective in the management of urdhwaga amlapitta |
Initial assessment at 0 day
ollow up at 10th,20th day
Final assessment at 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bhringraj yog is more effective than Avipattikar churna vati in the management of Urdhwaga amlapitta |
Initial assessment at 0 day
ollow up at 10th,20th day
Final assessment at 30th 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)
|
03/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/05/2025 |
| 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 an open randomised controlled clinical trial to evaluate the efficacy of bhringraj yog in the management of urdhwaga amlapitta w.s.r. to gastroesophageal reflux disease. Study will be carried out at OPD of kayachikitsa department of Late Kedari Redekar Ayurvedic Mahavidyalaya and hospital Gadhinglaj Kolhapur . The observation would be drawn on the basis of symptoms after treatment is given. |