| CTRI Number |
CTRI/2018/05/013948 [Registered on: 17/05/2018] Trial Registered Prospectively |
| Last Modified On: |
11/05/2018 |
| 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
|
Use of Katuki in treatment of Hyperacidity |
|
Scientific Title of Study
|
Therapeutical evaluation of Kaphapittahara karma of Katuki (Picrorhiza kurroa Royle ex Benth.) with special reference to Urdhwaga Amlapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirav Sondarva |
| Designation |
MD AYU Scholar Dravyaguna |
| Affiliation |
Government Ayurved College and Hospital Vadodara |
| Address |
Post Graduate Department of Dravyaguna
Government Ayurved College
Dhanvantari Marg
Opposite Panigate GSRTC Bus Depo
Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9409511411 |
| Fax |
|
| Email |
kakarott2890@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R C Pandey |
| Designation |
Professor |
| Affiliation |
Government Ayurved College and Hospital Vadodara |
| Address |
Post Graduate Department of Dravyaguna
Government Ayurved College
Dhanvantari Marg
Opposite Panigate GSRTC Bus Depo
Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9724824168 |
| Fax |
|
| Email |
0901rcp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Parmar |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurved College and Hospital Vadodara |
| Address |
Post Graduate Department of Dravyaguna
Government Ayurved College
Dhanvantari Marg
Opposite Panigate GSRTC Bus Depo
Panigate
Vadodara
GUJARAT
390019
India |
| Phone |
9558819463 |
| Fax |
|
| Email |
nehaa.parmarr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital Vadodara |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College and Hospital Vadodara |
| Address |
Government Ayurved College and Hospital
Dhanvantri Marg
Opposite Panigate GSRTC Bus Depo
Panigate
Vadodara 390019
Gujarat |
| 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 |
| Nirav Sondarva |
Government Ayurved College and Hospital Vadodara |
PG2 OPD Department of Dravyaguna
Vadodara
GUJARAT |
9409511411
kakarott2890@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 |
On the basis of signs and symptoms of Urdhwaga Amlapitta according to Ayurveda, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Katuki (Picrorhiza kurroa Royle ex Benth.) churna with Sarkara |
20 patients will be taken in Group B irrespective of their age, sex, religion, occupations and treated with Katuki churna with Sharkara in following dose and duration.
Dose: 2 gm (1 gm Katuki churna along with 1 gm of Sharkara) twice per day
Ausadha sevan kala: After meal
Duration: 2 weeks |
| Comparator Agent |
Yashtimadhu (Glycyrrhiza Glabra LINN) |
20 patients will be taken in Group A irrespective of their age, sex, religion, occupations and treated with Yashtimadhu Churna in following dose and duration.
Dose: 2 gm (Yashtimadhu Churna) thrice per day
Ausadha sevan kala: After meal
Duration: 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age group of 20-60 years.
Uncomplicated cases with classical signs and symptoms of Urdhwaga Amlapitta will be selected from the O.P.D. and I.P.D. sections
|
|
| ExclusionCriteria |
| Details |
Patients having age less than 20 years and more than 60 years.
Patients diagnosed with heamatemesis, acute diarrhoea, intestinal T.B., gastric and peptic ulcer, perforation, Systemic disorders like Diabetes & Hypertension, haemorrhoid, carcinoma, cardiac disorders & serious condition of the patient.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Observations will be assessed on the basis of improvement in the signs & symptoms of the disease mentioned in Classical texts |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of the therapy will be done by preparing clinical proforma. The obtain data will be analyzed statistically |
2 weeks |
|
|
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)
|
02/08/2018 |
| 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
|
Study will be published after completion of Trial |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a Randomized, Parallel Group, Open Label, Active Controlled trial to evaluate the efficacy of Katuki Churna in two divided doses with Sarkara for 2 weeks to 20 patients under Group B while in Group A Comparator agent which is Yashtimadhu churna will be administered in three divided doses with water for 2 weeks to 20 patients. The Clinical Data obtained will be summarized at the end of the study and conclusion will be made after the statistical analysis of the data |