| CTRI Number |
CTRI/2020/09/028034 [Registered on: 24/09/2020] Trial Registered Prospectively |
| Last Modified On: |
21/09/2020 |
| 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 Comparison of effect of Kantakaryadi Kwatha and Bhunimbadi Kwatha in Acidity |
|
Scientific Title of Study
|
A Comparative Phase 2 clinical study to evaluate efficacy of Kantakaryadi Kwatha and Bhunimbadi Kwatha in Urdhavag 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 Srajan Madhur Jain |
| Designation |
P G Student |
| Affiliation |
Ayurved seva sangh Ayurved mahavidyalaya nashik |
| Address |
OPD No 6 Kayachikitsa OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
8770103338 |
| Fax |
|
| Email |
srajan07jul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajan B Kulkarni |
| Designation |
Professor & HOD Kayachikitsa Dept |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik Maharashtra |
| Address |
OPD NO 6 Kayachikitsa OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9823350440 |
| Fax |
|
| Email |
vaidyarajankulkarni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajan B Kulkarni |
| Designation |
Professor & HOD Kayachikitsa Dept |
| Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik Maharashtra |
| Address |
OPD NO 6 Kayachikitsa OPD
Nashik
MAHARASHTRA
422003
India |
| Phone |
9823350440 |
| Fax |
|
| Email |
vaidyarajankulkarni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Srajan Madhur Jain
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 422003 |
|
|
Primary Sponsor
|
| Name |
Ayurved Mahavidyalaya Nashik |
| Address |
Ganeshwadi Panchvati Nashik |
| Type of Sponsor |
Other [State Govt Grant in aid Institute] |
|
|
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 Srajan Madhur Jain |
Arogyashala Rugnalaya |
OPD NO 6 Kayachikitsa Department
Nashik
MAHARASHTRA |
8770103338
srajan07jul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bhunimbadi Kwatha |
40 ml twice a daily before meal for 21 days |
| Intervention |
Kantakaryadi Kwatha |
40 ml twice a daily before meal for 21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Obesity induce hyperacidity
Patients fulfilling the diagnostic criteria which are based on sign and symptoms of amlapitta
|
|
| ExclusionCriteria |
| Details |
Patient not willing for clinical trial
Pregnant and lactating mothers
Patients suffering from any other chronic systemic disorders
stomach abnormality like hiatus hernia Connective tissue disorders such as scleroderma
Taking other medicine like aspirin ibuprofen Non steroidal anti inflammatory drugs High blood pressure medicine Iron supplements tricyclic antidepressants Anti-anxiety drugs etc
|
|
|
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 |
| Reduction of acid reflux |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of associate symptoms related to acidity |
21 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)
|
30/09/2020 |
| 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 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 - NO
|
|
Brief Summary
|
In modern era amlapitta is a most remarkable problem in the society it is a very common disease mostly affecting the adult men and women in the Indian population As the treatment the use of antacids which has symptomatic relief only Antacids that contain aluminum hydroxide may cause constipation aluminum intoxication osteomalacia and hypophosphatemia Kantakaryadi kwatha is a drug of choice for Amlapitta contain all the necessary ingredients that are useful to breakdown pathophysiology of Amlapitta by their rasa and virya properties Kantakaryadi kwatha will be preparaed as per reference mentioned in ayurvedic text under supervision of experts in Dept. Of Rasashastra & Bhaishajyakalpana of Ayurved Seva Sangh College Nashik and Bhunumbadi Kwatha is a drug of choice for parallel study It is prepared by a GMP certified Ayurvedic drug manufacturing company The clinical study to evaluate the efficacy of these drugs will be beneficial to the practitioners of Ayurveda throughtout the world so here study is designed to evaluate the efficacy of Kantakaryadi Kwatha internally twice a daily for 21 days and Bhunimbadi Kwatha internally twice a daily for 21 days in the management of Amlapitta |