| CTRI Number |
CTRI/2023/07/054798 [Registered on: 05/07/2023] Trial Registered Prospectively |
| Last Modified On: |
29/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of amlapittaghna arka and mishreya arka in the hyperacidity |
|
Scientific Title of Study
|
An open label double arm randomized comparative clinical study to evaluate the efficacy of amlapittaghna arka and mishreya arka in the management of urdhvaga amlapitta (non ulcer dyspepsia) |
| 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 Nikhil Chaudhari |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
7588318278 |
| Fax |
|
| Email |
cnikhil064@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu R |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9481328930 |
| Fax |
|
| Email |
dr.manurajgopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nikhil Chaudhari |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
7588318278 |
| Fax |
|
| Email |
cnikhil064@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara
391760 |
|
|
Primary Sponsor
|
| Name |
Parul Ayurved Hospital |
| Address |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara
391760 |
| 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 Nikhil Chaudhari |
PARUL AYURVED HOSPITAL |
OPD No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University PO Limda Tal Waghodia Gujarat Vadodara
391760
Vadodara
GUJARAT |
7588318278
cnikhil064@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mishreya Arka, Reference: Arka Prakash, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amlapittaghna Arka, Reference: Arka Prakash, Route: Oral, Dosage Form: Arka, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having symptoms of Amlapitta like Avipaka,Klama,Utklesha,Tikta-amla udgara,Hridaya kanthadaha,Gaurava and Aruchi
Chronicity upto 1 year |
|
| ExclusionCriteria |
| Details |
Patients of age below 18 years and above 50 years
Chronicity more than 1 year
Duodenal ulcer, Malignancy
Symptoms like Hematemesis and Malena
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Helps in reducing hyperacidity and abdomimnal discomfort |
Total 15 days of treatment will be there. During these 15 days, assessment will be done on 7th and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce sign & symptoms of hyperacidity (non ulcer dyspepsia) as follows
1) Bothersome postprandial fullness
2) Early satiety
3) Epigastric pain
4) Epigastric burning |
Total 15 days of treatment will be there. During these 15 days, assessment will be done on 7th & 15th day. |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 3 |
|
Date of First Enrollment (India)
|
15/07/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
AIM:- To evaluate the efficacy of Amlapittaghna arka and Mishreya arka in the
management of Urdhvaga Amlapitta (Non-ulcer dyspepsia)
OBJECTIVES :
• To study the effect of Amlapittaghna arka and Mishreya arka in the management of
Urdhvaga Amlapitta based on classical symptoms of Amlapitta
• To study the effect of Amlapittaghna arka and Mishreya arka in the management of
Urdhvaga Amlapitta based on GSRS Scale and CBC
• To compare Amlapittaghna arka and Mishreya arka. |