| CTRI Number |
CTRI/2023/03/050275 [Registered on: 02/03/2023] Trial Registered Prospectively |
| Last Modified On: |
01/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical trial to study the effect of Amalaki Churna in Gastro Esophageal Reflux Disease in Ayurvedic perspective |
|
Scientific Title of Study
|
An Epidemiological Study of Gerd (Gastro Esophageal Reflux Disease) in Ayurvedic Perspective and Evaluate the Efficacy of Amalaki Churna |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amarendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Patna Bihar |
| Address |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 800003 Bihar
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
9931230820 |
| Fax |
|
| Email |
singh.amrendra70@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Patna Bihar |
| Address |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 800003 Bihar
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
9931230820 |
| Fax |
|
| Email |
singh.amrendra70@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarendra Kumar Singh |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Patna Bihar |
| Address |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 800003 Bihar
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Bihar 800003
Patna
BIHAR
800003
India |
| Phone |
9931230820 |
| Fax |
|
| Email |
singh.amrendra70@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital Patna 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna Bihar |
| Address |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 800003 Bihar |
| Type of Sponsor |
Research institution and 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 Neha Yadav |
Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 800003 Bihar |
Department of Rog Nidan evam Vikriti Vigyan Government Ayurvedic College and Hospital Patna Aryabhatta Knowledge University Patna 800003 Bihar
Patna
BIHAR |
9675516561
nehastar20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
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: Amalaki Churna, Reference: Dravyagun Vigyan- P.V. Sharma Volume 2 Pg. no.759, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: - Luke warm water), Additional Information: -Amalaki is a well known drug having Tridosha Hara properties (specially Pittahara). It acts as Rochana, Deepana, Anulomana and Amlataa Nashaka. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The Patients having age between 20- 60 years.
2. The sign and symptoms of GERD as well as
Amlapitta, Vidagdhajirna based on both Ayurvedic
as well as modern view.
|
|
| ExclusionCriteria |
| Details |
1. Age above 60 and less than 20 years.
2. Immunocompromised patients e.g. HIV etc.
3. Patient is unwilling.
4. Patient with complicated associated symptoms i.e.
severely ill. e.g. Liver cirrhosis,
Adenocarcinoma. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of acid reflux. |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in symptoms like indigestion, fatigue, nausea, sour and bitter belching, heaviness, anorexia etc. |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
04/03/2023 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
GERD is one of the most prevalent gastrointestinal disorders. The classical triad of symptoms is retrosternal burning pain (heart burn), epigastric pain and regurgitation. Present study is planned for the management of GERD in ayurvedic perspective including Amlapitta and Vidagdhajirna with the drug Amalaki Churna mentioned in Ayurveda text with the hope that it will prove more efficacious and easy to use. Total 50 patients will be registered randomly from OPD and IPD of Rog Nidan evam Vikriti Vigyan Department of Government Ayurvedic College and Hospital Patna. Duration of trial is 60 days. |