| CTRI Number |
CTRI/2025/07/090441 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study to compare effectiveness of Nistushayawadi Kwatha and Kantakaryadi Kwatha in management of Urdhwaga Amlapitta (Gastroesophageal Reflux Disease) |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate efficacy of Nistushayawadi Kwatha and Kantakaryadi Kwatha in management of Urdhwaga Amlapitta (Gastroesophageal Reflux Disease) |
| 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 Prayer Pandharinath Patil |
| Designation |
PG Scholar |
| Affiliation |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital,Chhatrapati Sambhajinagar |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital,Kayachikitsa Department Hospital Building 4th floor Nipani Bhalgoan ,Chhatrapati Sambhajinagar(Aurangabad)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9145476279 |
| Fax |
|
| Email |
prayerpatil1234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Subhashrao Solanke |
| Designation |
Associate Professor |
| Affiliation |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital,Kayachikitsa Department Hospital Building 4th floor Nipani Bhalgoan ,Chhatrapati Sambhajinagar(Aurangabad)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
7447801802 |
| Fax |
|
| Email |
meerasolanke20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meera Subhashrao Solanke |
| Designation |
Associate Professor |
| Affiliation |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital,Kayachikitsa Department Hospital Building 4th floor Nipani Bhalgoan ,Chhatrapati Sambhajinagar(Aurangabad)
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
7447801802 |
| Fax |
|
| Email |
meerasolanke20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital Kaychikitsa Department Hospital Building 4th floor Nipani Bhalgaon Chhatrapati Sambhajinagar (Aurangabad)
Dist Aurangabad
Maharashtra - 431005
India |
|
|
Primary Sponsor
|
| Name |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
| Address |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital Kaychikitsa Department Hospital Building 4th floor Nipani Bhalgaon Chhatrapati Sambhajinagar (Aurangabad)
Dist Aurangabad
Maharashtra - 431005
India |
| Type of Sponsor |
Private medical college |
|
|
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 Prayer Pandharinath Patil |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College And Hospital |
Shiva Trusts Yashwantrao Chavan Ayurvedic Medical College and Hospital Kaychikitsa Department Hospital Building 4th floor
Aurangabad
MAHARASHTRA |
9145476279
prayerpatil1234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K21||Gastro-esophageal reflux disease. Ayurveda Condition: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nistushayawadi Kwatha, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Ksohna jala), Additional Information: 1)Nistushayawa – 1 part
2) Vasa – 1 part
3) Amalaki – 1 part
4) Twaka– 4 ratti
5) Elaichi – 4 ratti
6) Tejpatra– 4 ratti
7) Madhu– 1 tola
8) Jala– 4th part | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kantakaryadi Kwatha, Reference: Yogratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: 1) Kantakari – 1 part
2) Guduchi– 1 part
3) Vasa– 1 part
4) Madhu– 1/8th part
5) Jala– 4th part |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with Lakshanas of Urdhwaga Amlapitta as mentioned in Madhav Nidana (51/2) such as Avipak (Indigestion) , Klama (tiredness) , Utklesha (Nausea) , Tiktamlodgar (sour and bitter belching),Gaurav (Heaviness in the body) , Hrit-Kantha daha (Burning sensation at epigastrium and chest) , Aruchi (Anorexia) |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Not willing for trial or non-cooperative patients.
3. Patients those are positive for HIV, HbsAg and alcohol addiction, etc.
4. Patients who cannot interrupt steroid, non-steroid anti-inflammatory drugs.
5. Patients with past history of GI surgery and chronic diseases.
6. Participants with peptic and duodenal ulcers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Nistushayawadi kwatha and Kantakaryadi kwatha in management of Urdhwaga Amlapitta with special reference to GERD |
follow up - 0, 7th, 14th, 21th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Nistushayawadi kwatha and Kantakaryadi kwatha in Urdhwaga Amlapitta with special reference to GERD |
follow up - 0, 7th, 14th, 21th day |
| To compare the efficacy of Nistushayawadi kwatha and Kantakaryadi kwatha in Urdhwaga Amlapitta with special reference to GERD |
|
| To study Urdhwaga Amlapitta in brief from Ayurvedic and Modern perspective |
|
| To study in brief about Nistushayawadi kwatha and Kantakaryadi kwatha |
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/07/2025 |
| 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 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
|
Amlapitta is a disease of Annavahasrotas. It is Pitta-kapha pradhana Tridoshaja vyadhi. The term amlapitta itself states, increased Amlatva of Pitta dosha.Acharya Sushruta has mentioned Katu rasa as predominant rasa of pitta and when pitta becomes vidagdha it changes into amla rasa.Udrikta stands for increased or excessive, which means that there is quantitative increase in amla guna of pitta which leads to Amlapitta. Also Vitiated Agni leads to increased Amlaguna (sour taste) of Pachak pitta, resulting in Samata.Various The signs & symptoms of Urdhwaga Amlapitta mostly resemble with the symptoms of Gastro Oesophageal Reflux Disease (GERD) such as dyspepsia, heartburn, indigestion, nausea, sour belching, food regurgitation, chest pain, gastric discomfort, abdominal distension, reduced appetite. Taking this in consideration correlation is drawn between Urdhwaga Amlapitta and gastroesophageal reflux disease (GERD).GERD is the most common esophageal disorder, accounting for nearly 75% of all patients with esophageal disorders.Also Gastroesophageal reflux resulting in heartburn affects approximately 30% of the general population. In the Indian population, the combined prevalence of Gastro oesophageal Reflux Disease (GERD) stands at 15.6%.In modern medicine science treatment of GERD focus on lifestyle modification and pharmacologic approach i.e inhibitors of gastric acid secretion. The drugs H2 blockers and proton pump inhibitors (PPI) are commonly used for this purpose. Recurrence of symptoms is common when therapy is stopped and some patients require life-long treatment at lowest acceptable dose. To overcome this limitations, Ayurveda’s treatment principles, that believe in treating the root cause of disease may give promising treatment options. Nistushayawadi kwatha and Kantakaryadi kwatha mentioned in Bhaishajyaratnali and Yogratnakar respectively are two among those different formulations. Separate individual studies has been carried out in order to know efficacy of these formulations in Amlapitta. The goal of this current study is to compare effectiveness of Nistushayawadi kwatha and Kantakaryadi kwatha in treating Urdhwaga Amlapitta. |