| CTRI Number |
CTRI/2018/07/014802 [Registered on: 10/07/2018] Trial Registered Prospectively |
| Last Modified On: |
09/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effectiveness of dhattura lavana, a folklore medicine in the management of patients of alcoholic dependence |
|
Scientific Title of Study
|
A clinical study on effectiveness of dhattura lavana- A folklore medicine in madatyaya (Alcohol dependence) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAjith KumarG |
| Designation |
PG scholar |
| Affiliation |
Rajiv gandhi university of health science |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
8281664144 |
| Fax |
|
| Email |
drakg1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Savitha HP |
| Designation |
Associate Professor,Department of manovijyan evam manas roga |
| Affiliation |
Rajiv gandhi university of health science |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9980168208 |
| Fax |
|
| Email |
savithem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Savitha HP |
| Designation |
Associate professor |
| Affiliation |
Rajiv gandhi university of health science |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India, Department of manasa roga
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
Hassan
KARNATAKA
573201
India |
| Phone |
9980168208 |
| Fax |
|
| Email |
savithem@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
|
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara
College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 Karnataka India
|
| Type of Sponsor |
Private medical college |
|
|
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 Ajith KumarG |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
Department of manovijyana evam manasa roga, room no 4
Hassan
KARNATAKA |
8281664144
drakg1991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Madatyaya (Alcoholic Dependence), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DHATTURA LAVANA (Dhattura metel and rock salt) |
2.5 gram BD for 30 days along with buttermilk after food |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.male or a non pregnant/non nursing female
between 20 and 70 years of age.
2.subjects fulfilling the criteria for alcohol
dependence according to ICD-10.
3.Be willing to give informed consent and comply
with study procedures. |
|
| ExclusionCriteria |
| Details |
1. Subjects suffering from organic brain
diseases.
2 Current use of any psychoactive medication
3. Subjects fulfilling ICD-10 criteria for the following axis 1 disorders: Schizophrenia, bipolar disorder, major depression or any other substance dependence disorder (excluding nicotine)
• Previous withdrawal-induced delirium tremens or seizures
• Presence of any serious somatic disorder e.g. liver cirrhosis
• Presence of any previous heart disease of clinically significant ECG abnormality e.g. arrhythmias, bundle branch block or QT interval or T wave alterations
• Use of any illegal narcotic drugs the last 30 days before screening
Presence of diseases like diabetes mellitus, HIV,HbSag,Ishaemic Heart Diseases
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reduce the dependency of alcohol.Parameters used to assess the reduction in dependency is by alcohol dependence scale and LFT |
37 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
maintain liver function within
normal limits |
37 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2018 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The current study will be open labeled single arm (uncontrolled) exploratory clinical trial at outpatient department and inpatient department basis with pre and post-test design. Included 30 patients will be treated with Dhattura saindhava lavana, conducted in Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, located in district headquarter in Southern India. 2.5 gram of dhattura lavana along with butter milk after food will be providing to 30 patients. The primary outcome is to reduce the dependency of alcohol in patients and the secondary outcome is to maintain the liver function within normal limits. |