| CTRI Number |
CTRI/2026/02/102923 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| 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 to see the effect of Polyherbal Formulation and Praval Panchamrut in management of acid reflux disease. |
|
Scientific Title of Study
|
Evaluation of Efficacy of Polyherbal Formulation in Amlapitta (Gastro esophageal Reflux Disease): A Randomized Controlled Trial. |
| 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 Renuka Digambar Kapade |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Maharashtra Kayachikitsa OPD No.5
Pune
MAHARASHTRA
411018
India |
| Phone |
9011482045 |
| Fax |
|
| Email |
renuka.kapde12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr DG Dipankar |
| Designation |
HOD Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Maharashtra Kayachikitsa OPD No.5
Pune
MAHARASHTRA
411018
India |
| Phone |
9822279321 |
| Fax |
|
| Email |
digambar.dipankar@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renuka Digambar Kapade |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil College of Ayurved and Research Centre |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Maharashtra Kayachikitsa OPD No.5
Pune
MAHARASHTRA
411018
India |
| Phone |
9011482045 |
| Fax |
|
| Email |
renuka.kapde12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr. Renuka Digambar Kapade |
| Address |
Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Maharashtra 411018 Kayachikitsa OPD No.5 |
| 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 Renuka Digambar Kapade |
Dr. D. Y. Patil College of Ayurved and Research Centre |
OPD No 5 Kayachikitsa Department, Dr. D. Y. Patil College of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune Maharashtra 411018
Pune
MAHARASHTRA |
9011482045
renuka.kapde12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR. DYPCA and RC INSTITUTIONAL ETHICS COMMITTEE |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Praval Panchamrut, Reference: Bhaishajya Ratnavali Gulma Rogadhikara shlok 139-143, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Guduchi, Nimb, Patola, Kirattikta, Musta, Yashtimadhu, Haritaki, Bibhitaki, Amalaki, Parpataka, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with classical symptoms of Amlapitta like Avipaka(Indigestion),Tikta-Amla Udgara(sour and bitter belching),Hridkanth Daha(Heart and throat burn) associated with or without Klama(tiredness),Utklesha(nausea),Aruchi(anorexia)
2)Age limit from 18 to 60 years.
3)Patients who are willing and able to adhere to study protocol, including prescribed treatment and follow up schedules. |
|
| ExclusionCriteria |
| Details |
1)Patients suffering from any serious systemic disease.
2)Patients suffering from CA stomach.
3)Patients suffering from GI disorders like Peptic ulcer, Pancreatic diseases.
4)Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Reduction in classical symptoms of Amlapitta such as Avipaka(Indigestion),Tikta-Amla Udgara(Sour and bitter belching),Hridkanth Daha(Heart and throat burn)
2)Reduction in GERD-HRQL Questionnaire score |
14 days study
Follow up on 7th and 14th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/03/2026 |
| 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
|
To study the effect of Polyherbal Formulation 40ml kwath on 27 patients comparing with Praval Panchamrut 250mg 2BD before food on 27 patients suffering from Amlapitta(Gastro esophageal Reflux Disease). Total 54 patients will be enrolled having sign and symptoms of Amlapitta for 14 days and follow up will be done on 7th and 14th day. Final conclusion will be drawn on basis of statistical method. |