| CTRI Number |
CTRI/2022/09/045217 [Registered on: 05/09/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2022 |
| 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
|
A clinical trial to study the effect of Kantakaryadi kashayam and Aragwadhamrutadi Kashayam in Gastritis |
|
Scientific Title of Study
|
An Open Label Double Arm Randomized Comparative Clinical Study On The Efficacy Of Kantakaryadi Kashayam And Aragwadhamrutadi Kashayam in Amlapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Arun G Nair |
| Designation |
PG Scholar |
| Affiliation |
Dhanvantari Ayurveda College and Hospital |
| Address |
Dhanvantari Ayurveda College and Hospital, siddapur, Karnataka
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
7907056436 |
| Fax |
|
| Email |
arungnair9400@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Roopa Bhat |
| Designation |
H OD Dept of Kayachikitsa |
| Affiliation |
Dhanvantari Ayurveda College and Hospital |
| Address |
Dhanvantari Ayurveda College and Hospital, siddapur, Karnataka
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
9845301333 |
| Fax |
|
| Email |
ayurroopa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Arun G Nair |
| Designation |
PG Scholar |
| Affiliation |
Dhanvantari Ayurveda College and Hospital |
| Address |
Dhanvantari Ayurveda College and Hospital, siddapur, Karnataka
Uttara Kannada
KARNATAKA
581355
India |
| Phone |
7907056436 |
| Fax |
|
| Email |
arungnair9400@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dhanvantari Ayurveda Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
DR Arun G Nair |
| Address |
Dhanvantari Ayurveda Medical College and Hospital, Siddapur, Karnataka |
| Type of Sponsor |
Other [Others] |
|
|
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 Arun G Nair |
Dhanvantari Ayurveda Hospital |
Dhanvantari Hospital
Kayachikitsa department
Opd 1
Dhanvantari Ayurveda College and Hospital, Siddapur
Uttara Kannada
KARNATAKA |
7907056436
arungnair9400@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:K297||Gastritis, unspecified. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kantakaryadi Kashayam, Reference: Yogaratnakara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aragwadhamrutadi Kashayam, Reference: Sahasrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Classical Signs of Amlapitta
2.Patients with chronicity less than 5years |
|
| ExclusionCriteria |
| Details |
1.patients with Age<16yrs and >60yrs
2.Patients with H/o Gastric Ulcer,Duodenal Ulcer,Gastric Carcinoma etc.
3.Patients with H/O Haemetaemesis,Melaena and Anaemia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Kantakaryadi Kashayam is more effective compared to Aragwadhamrutadi Kashayam in Amlapitta |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of recurrence of symptoms reduced significantly |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/09/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [arungnair9400@gmail.com].
- For how long will this data be available start date provided 05-08-2023 and end date provided 05-08-2035?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, double blind, parallel group, multicentre trial comparing the efficacy of Kantakaryadi Kashayam and Aragwadhamrutadi Kashayam in Amlapitta for 30 days in 40 patients with classical signs of Amlapitta that will be conducted in Dhanvantari Ayurveda Medical College and Hospital, Siddapur,Karnataka, India.
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