| CTRI Number |
CTRI/2024/09/074263 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
18/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to compare haritakyadi churna and avipattikara churna in the management of hyper acidity |
|
Scientific Title of Study
|
A comparative clinical study on the efficacy of haritakyadi churna and avipattikara churna in the management of urdhwaga amlapitta w.s.r.to 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 Prajakta Haridas Jori |
| Designation |
PG scholar |
| Affiliation |
sst ayurved medical college sangamner |
| Address |
OPD number 5 kayachikitsa OPD ground floor sst ayurved hospital sangamner tal sangamner dist ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9284649948 |
| Fax |
|
| Email |
prajaktajori6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilesh Dere |
| Designation |
Professor |
| Affiliation |
sst ayurved medical college sangamner |
| Address |
OPD number 5 kayachikitsa OPD ground floor sst ayurved hospital sangamner tal sangamner dist ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9271292389 |
| Fax |
|
| Email |
dr.nilesh.dere@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nilesh Dere |
| Designation |
Professor |
| Affiliation |
sst ayurved medical college sangamner |
| Address |
OPD number 5 kayachikitsa OPD ground floor sst ayurved hospital sangamner tal sangamner dist ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9271292389 |
| Fax |
|
| Email |
dr.nilesh.dere@gmail.com |
|
|
Source of Monetary or Material Support
|
| sst ayurved medical college sangamner tal. sangamner dist. ahmadnagar maharashtra pincode 422605 |
|
|
Primary Sponsor
|
| Name |
Dr Prajakta Haridas Jori |
| Address |
OPD no 5 kayachikitsa OPD Ground Floor Sst Ayurved Hospital sangamner Tal sangamner Dist ahmadnagar 422605 |
| 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 Prajakta Haridas Jori |
Sst Ayurved Hospital sangamner |
OPD number 5 kayachikitsa OPD ground floor sst ayurved hospital sangamner tal. sangamner dist. ahmadnagar
Ahmadnagar
MAHARASHTRA |
9284649948
prajaktajori6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sst ayurved mahavidyalaya sangamner 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: URDHVAGATA-AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi churna, Reference: Bhavprakash nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Avipattikara churna, Reference: bhaishjya ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 4 Weeks, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Presenting with classical symptoms of amlapitta such as tikta-amlodgara (sour & bitter belching)
2 Hrita-Kantha Daha
3 Aruchi (Anorexia)
4 Utklesha(Nausea)
5 Avipaka(Indigestion)
6 Klama (Tiredness)
7 Gauravata(Abdominal Fullness) |
|
| ExclusionCriteria |
| Details |
1 known case of bleeding disorders
2 Patients suffering from known systemic illness which interfere with course of treatment
3 Diagnosed case of Helicobacter pylori
4 Pregnant women, lactating mother, alcoholic persons
5 known case of High risk Diseases such as diabetes,HTN
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to studt the efficacy of Haritakyadi churna in the management of urdhwaga amlapitta |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the effect of haritakyadi churna & avipattikara churna in the management of urdhwaga amlapitta |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
16/10/2024 |
| 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="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
|
As we see the number of patients with hyper
acidity are increased now a days so this study will help the patients for
reducing hyper acidity and symptoms like heart burn and nausea. This study is A comparative clinical study on the efficacy of
haritakyadi churna and avipattikara churna in the management of urdhwaga
amlapitta w.s.r.to non ulcer dyspepsia . both drugs are given in the form of powder for the
diagnosed cases of urdhwaga amlapitta for 4 weeks. 40 patients in each group will
be studied. Study will be conducted in India. Outcome of study will be asses on
reducing hyper acidity and symptoms like heart burn and nausea |