| CTRI Number |
CTRI/2024/06/068578 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Amlapittanashaka Yoga Over Avipattikara Churna in the management of Amlapitta with special reference to Hyperacidity |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Study to assess the efficacy of Amlapittanashaka Yoga over Avipattikara Churna in the management of Urdwaga Amlapitta with special reference to Hyperacidity |
| 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 Kiran CM |
| Designation |
PG Scholar |
| Affiliation |
BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Kayachikitsa, BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri, Vijayapura, Karnataka
Bijapur
KARNATAKA
586109
India |
| Phone |
9845707337 |
| Fax |
|
| Email |
kirancm1.98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Kayachikitsa, BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri, Vijayapura, Karnataka
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay M Kadlimatti |
| Designation |
Principal and Professor |
| Affiliation |
BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Department of Kayachikitsa, BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri, Vijayapura, Karnataka
Bijapur
KARNATAKA
586109
India |
| Phone |
8970744656 |
| Fax |
|
| Email |
ayursanjay@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri, Vijayapura, Karnataka |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Kiran CM |
BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vijayapura |
Department of Kayachikitsa No.10, BLDE Associations AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Bagalkot road, Vidya Nagar, Murankeri, Vijayapura, Karnataka
Bijapur
KARNATAKA |
9845707337
kirancm1.98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee BLDEA AVS Ayurveda Mahavidyalaya Hospital and research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K210||Gastro-esophageal reflux disease with esophagitis. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avipattikara Churna , Reference: Bhaishajya Ratnavali, Athamlapittachikitsaprakaran 56/ 25- 29, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amlapittanashaka Yoga , Reference: Bhaishajya Ratnavali, Athamlapittachikitsaprakaran 56/14, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information:
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed as Urdwaga Amlapitta as per diagnostic criteria.
Subjects willing and able to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patient presenting with bahudosha avastha that may require Shodhana chikitsa.
Patients with H/O haematemesis, malena and other systemic disorders that may interfere with clinical trial.
K/c/o IBS, Psychiatry illness, Bleeding disorders, Diabetes Mellitus and Uncontrolled Hypertension.
Substance abuse symptoms like alcohol, caffeine etc.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in epigastric congestion, sour belching and gastritis |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms like headache, nausea & anorexia |
28 days |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="2"
Months="0"
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
|
This study is Randomized Comparative Clinical study to assess the efficacy of Amlapittanashaka Yoga over Avipattikara Churna in the Management of Urdwaga Amlapitta that will be conducted in BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre,Vijayapur -58109 Karnataka, India |