| CTRI Number |
CTRI/2025/05/086950 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of Dhanyakadi Churna and Panchnimbadi Churna in 62 patients of Urdhwag Amlapitta or Gastro Oesophageal Reflux Disease. |
|
Scientific Title of Study
|
An Open, Randomized, Comparative Clinical Study of Dhanyakadi Churna and Panchnimbadi Churna in the Management of Urdhwag Amlapitta |
| 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. Nisha Sahebrao Tarte |
| Designation |
PG Scholar |
| Affiliation |
APMS Ayurved Mahavidyalaya Sion |
| Address |
203,Yashraj Heights,Sector No.23,Gothivali Gaon,Navi Mumbai
Department of Kayachikitsa,Fourth floor,APMS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East ,Mumbai 400022
Mumbai
MAHARASHTRA
400701
India |
| Phone |
9082901128 |
| Fax |
|
| Email |
tartenisha27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nisha Sahebrao Tarte |
| Designation |
PG Scholar |
| Affiliation |
APMS Ayurved Mahavidyalaya Sion |
| Address |
203,Yashraj Heights,Sector No.23,Gothivali Gaon,Navi Mumbai
Department of Kayachikitsa,Fourth floor,APMS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East,Mumbai 400022
Mumbai
MAHARASHTRA
400701
India |
| Phone |
9082901128 |
| Fax |
|
| Email |
tartenisha27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anaya Ashish Pathrikar |
| Designation |
HOD and Professor |
| Affiliation |
APMS Ayurved Mahavidyalaya Sion |
| Address |
Department of Kayachikitsa,Fourth floor,APMS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East,Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9870214595 |
| Fax |
|
| Email |
anayapathrikar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth R V Ayurved Hospital |
|
|
Primary Sponsor
|
| Name |
Seth R V Ayurved Hospital |
| Address |
Seth R V Ayurved Hospital and APMS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East ,Mumbai 400022 |
| Type of Sponsor |
Other [Charitable Ayurvedic Hospital] |
|
|
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 Nisha Sahebrao Tarte |
Seth R V Ayurved College and Hospital |
APMS Ayurved Mahavidyalaya, Near Sion Railway Station, Sion East, Mumbai 400022
Mumbai
MAHARASHTRA |
09082901128
tartenisha27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| APMS Ayurved Mahavidyalaya Sion |
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: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhanyakadi Churna, Reference: RASRATNAKAR, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -HONEY), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PANCHNIMBADI CHURNA, Reference: CHAKRADATTA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: HONEY), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 60 years
Gender All genders
Symptoms Urdhwag Amlapitta Hrit Kantha Dah, Tikt Amlodgar, Utklesha, Avipak, Aruchi, Klama.
Compliance Patients who are willing and able to adhere to the study protocol, including prescribed treatments and follow-up schedules.
Health Status Patients with no significant comorbidities that could interfere with the Study outcomes or the safety of the participant, as determined by a clinical assessment.
Medication History Patients who have not used any other Ayurvedic or allopathic treatments for Urdhwag Amlapitta in the past two weeks.
|
|
| ExclusionCriteria |
| Details |
Pregnancy and Lactation
Psychiatric Disorders
Chronic or Severe Medical Conditions
Recent Surgery
Current Use of Confounding Medications
Substance Abuse
Participation in Other Trial |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hrit Kantha daha
Tikta amlodgar
Utklesha
Avipak
Aruchi
Klama
|
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
02/06/2025 |
| 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 primary objective of this open, randomized, comparative clinical study is to evaluate and compare the efficacy of Dhanyakadi Churna and Panchnimbadi Churna in the management of Urdhwag Amlapitta, a condition in Ayurveda correlating with gastroesophageal reflux disease (GERD), characterized by symptoms such as indigestion, nausea, sour belching, burning sensations in the chest and throat, and fatigue. Rooted in Ayurvedic principles, Urdhwag Amlapitta is believed to arise from the vitiation of Pitta dosha due to lifestyle and dietary factors. This clinical trial includes 62 patients, randomly assigned into two groups (31 each), with both groups receiving their respective churna at a dose of 3 grams twice daily for 21 days, administered with honey. The primary hypothesis posits that both formulations are equally effective in treating Urdhwag Amlapitta, while secondary hypotheses explore whether one treatment demonstrates superior efficacy over the other. The study seeks to provide scientific evidence for the use of these Ayurvedic formulations as viable alternatives to conventional pharmacological treatments.
|