| CTRI Number |
CTRI/2025/02/080924 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Amrutadi Kwatha in the management of Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease. |
|
Scientific Title of Study
|
A randomized open labelled controlled clinical study to evaluate the efficacy of Amrutadi Kwatha in the management of Urdhwaga Amlapitta with special reference to 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 Savinaya K |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
OPD No.5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli Bangalore
Bangalore
Karnataka
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
8748002864 |
| Fax |
|
| Email |
savinaya1999k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopalakrishna G |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli Bangalore
Bangalore
Karnataka
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9448173128 |
| Fax |
|
| Email |
lakshmimp1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopalakrishna G |
| Designation |
Professor and HOD |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
| Address |
Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli Bangalore
Bangalore
Karnataka
560082
India
Bangalore
KARNATAKA
560082
India |
| Phone |
9448173128 |
| Fax |
|
| Email |
lakshmimp1981@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Road, Udayapura Post, Bangalore, Karnataka 560082 India |
|
|
Primary Sponsor
|
| Name |
Dr Savinaya K |
| Address |
OPD No.5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli Bangalore Karnataka
560082 India
Bangalore
Karnataka
560082
India |
| 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 Savinaya K |
Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore |
OPD No.5 Dept of PG Studies in Kayachikitsa Sri Sri College of Ayurvedic Science and Research Hospital 21st Km Kanakapura Rd Udayapura PO OB Chudahalli Bangalore
Bangalore
Karnataka
560082
India
Bangalore
KARNATAKA |
8748002864
savinaya1999k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI SRI INSTITUTIONAL ETHICAL 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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amrutadi Kwatha, Reference: Vangasena Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhasyaadi Kwatha, Reference: Cakradatta, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either gender between age of 21-60 years.
2. Subjects freshly diagnosed with Urdhwaga Amlapitta (Gastroesophageal reflux disease) who are not on any interventions presenting the cardinal symptoms - Tikta amlodgara, Kantadaha, Hritdaha with or without associated symptoms like Klama, Gaurava, Avipaka, Aruchi, Chardi, Utklesha, Shiroruja.
3. Subjects who are willing to give informed written consent. |
|
| ExclusionCriteria |
| Details |
1. Subjects diagnosed with Gastroesophageal reflux disease caused due to any other secondary conditions.
2. Subjects with diagnosed cases of erosive and post operative Gastroesophageal reflux disease.
3. Subjects suffering from any uncontrolled systemic disorders which will interfere with the course of disease and course of treatment.
4. Pregnant and Lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in symptoms of Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease based on subjective parameters is assessed. |
0th day - Before intervention
15th day - During intervention
30th day - After intervention
45th day - Drug free follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Generation of in depth analyzed data on the different aspects of the disease |
0th day - Before intervention
15th day - During intervention
30th day - After intervention
45th day - Drug free follow up |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/03/2025 |
| 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 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
|
ยท Amlapitta is the disease of Annavaha and Rasavaha Srotas which is classified according to pravrutti into two categories; Urdhwaga and Adhoga Amlapitta . Amlapitta is one of the major diseases caused by lifestyle changes as its prevalence is increasing day by day. Gastroesophageal reflux disease (GERD) is defined as retrograde flow of gastric contents into esophagus, characterised by heartburn, acid regurgitation . Gastroesophageal reflux disease is one of the most common chronic disorders of the gastro intestinal system. The incidence of GERD is high in general population, it is estimated to affect up to 20% of the population worldwide. (2019) The prevalence of GERD in India ranges from 7.6% to 30%, being < 10% in most population studies, and higher in cohort studies in 2019. The pooled prevalence of GERD in Indian population is 15.6% in 2021. K 21.9 is the ICD-10-CM code used for diagnosing Gastroesophageal reflux disease. EB-04 is the National Ayurveda morbidity code for Amlapitta. Commonly used pharmacological contemporary medicines include Proton pump inhibitors like Omeprazole, Pantoprazole, Lansoprazole which can cause adverse effects like headache, diarrhoea , Antacids like Calcium carbonate, Aluminium hydroxide cause adverse effects like constipation, abdominal pain. (11) H2 receptor blockers like Ranitidine, Famotidine cause adverse effects like constipation, fatigue, headache. Considering the prevalence, adverse effects and dependence on contemporary interventions, it is highly relevant to search for an effective formulation to manage Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease. Hence the study is opted. Amrutadi Kwatha mentioned in Vangasena Samhita under the context of Amlapitta Adhikara consists of Guduchi, Nagara, Musta, Kiratatikta. These ingredients are attributed with Tridosha hara, Deepana, Pachana property. Hence, considering the above background, it was thought worthy to evaluate the efficacy of oral administration of Amrutadi Kwatha in Urdhwaga Amlapitta with special reference to Gastroesophageal reflux disease. Simhasyaadi Kwatha mentioned in Cakradatta under the context of Amlapitta Adhikara, consists of Vasa, Guduchi, Brihati. Simhasyaadi Kwatha being a proven drug for Amlapitta, is taken as the control drug for the present study. |