| CTRI Number |
CTRI/2011/09/002003 [Registered on: 13/09/2011] Trial Registered Retrospectively |
| Last Modified On: |
09/09/2011 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical effect of Vasa Khanda Kushmanda Avaleha and Shunthi Khanda on Acidity
Shunthi Khanda acts on Hypoacidity and Khanda Kushmanda Avaleha acts on Hyperacidity and both are in granules form |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE ROLE OF DOSHIK PREDOMINANCE IN THE MANAGEMENT OF 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 Kuntal Ghosh |
| Designation |
PhD Scholar |
| Affiliation |
IPGT and RA |
| Address |
Dept of Kayachikitsa
IPGT and RA
Gujarat Ayurved University
Jamnagar
Room no 98
PG Boys Hostel
IPGT and RA
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
09727221291 |
| Fax |
|
| Email |
vaidyakuntal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Proffesor M S Baghel |
| Designation |
Director |
| Affiliation |
IPGT and RA |
| Address |
Dept of Kayachikitsa
Institute Of Post Graduate Training And Research In Ayurveda
Gujarat Ayurved University
Jamnagar
Director
Institute Of Post Graduate Training And Research In Ayurveda
Gujarat Ayurved University
Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
09427207964 |
| Fax |
02882676856 |
| Email |
baghelayu@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kuntal Ghosh |
| Designation |
PhD Scholar |
| Affiliation |
IPGT and RA |
| Address |
Dept of Kayachikitsa
IPGT and RA
Gujarat Ayurved University
Jamnagar
Room no 98
PG Boys Hostel
IPGT and RA
Gujarat Ayurved University
Jamnagar
GUJARAT
361008
India |
| Phone |
09727221291 |
| Fax |
|
| Email |
vaidyakuntal@gmail.com |
|
|
Source of Monetary or Material Support
|
| IPGT and RA
Gujarat Ayurved University
Jamnagar |
|
|
Primary Sponsor
|
| Name |
IPGT and RA |
| Address |
IPGT and RA
Gujarat Ayurved University
Jamnagar |
| 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 Kuntal Ghosh |
OPD and IPD IPGT and RA |
IPGT and RA
Gujarat Ayurved University
Jamnagar
Jamnagar
GUJARAT |
09727221291
vaidyakuntal@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 |
Patients suffering from cardinal sign and symptoms of Amlapitta as mentioned in Ayurvedic classics like Acid indigestion Heart burn Eructation Nausea Regurtitatiuon Vomiting Lassitude, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Shunthi Khanda |
5 g BD for 30 days |
| Comparator Agent |
Vasa Khanda Kushmandaka Avaleha |
5 g BD for 30 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Presence of Pratyatmaka Laksanas of Amlapitta
Chronicity- more than 3 months duration |
|
| ExclusionCriteria |
| Details |
Chronicity of the disease less than 3 months
Patients with Peptic Ulcer
Duodenal Ulcer
CA Stomach
Cardiac disorders.
Taking medicines for any other diseases like Hypertension
Diabetes Mellitus
Ischemic Heart Diseases
Chronic Renal Failure |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Roga bala ( severity of disease)
Agni bala ( power of digestion)
Deha bala ( strength of the body) and Chetas bala ( mental strength)
Brief Psychiatric rating scale
Subjective and objective signs and symptoms |
Assessment will be done on every week based on scoring of cardinal symptoms |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| exacerbations in signs and symptoms |
1 week |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
17/08/2011 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial is a randomized open clinical trial for assessing the Doshic predominence in Amlapitta wsr to the efficacy of Vasa Khanda Kushmandaka Avaleha and Shunti Khanda in granules form, each 5 g BD for 30 days |