| CTRI Number |
CTRI/2024/12/078386 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess and compare the Single cause types of Alcoholism Symptoms in chronic
alcoholic person with special reference to Serum Gamma Glutamyl Transferase
test. |
|
Scientific Title of Study
|
Assessment of Ekdoshaj types of Madatyaya Lakshanas in Chronic Alcoholic
Person with special reference to Serum Gamma Glutamyl Transferase test
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Nituja Sanjay Ethape |
| Designation |
PG Scholar |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8208852568 |
| Fax |
|
| Email |
nitujaethape@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satyendra Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi
Pune
Pune
MAHARASHTRA
144044
India |
| Phone |
9890741683 |
| Fax |
|
| Email |
drsatyendra1981@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Nituja Sanjay Ethape |
| Designation |
PG Scholar |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8208852568 |
| Fax |
|
| Email |
nitujaethape@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre,Sector No.27,Pradhikaran,Nigdi,Pune,
Mahrashtra 411044 |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [] |
|
|
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 |
| Vd Nituja Sanjay Ethape |
Pathology lab room no 115 ,PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital ARSMH |
Near Sant Dyaneshwar
Chowk,Sector No.
27,Pradhikaran
,Nigdi,Pune 411044
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8208852568
nitujaethape@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Alcoholic person consuming Madya from 3 to 10 years |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
1)Male Persons of Age Group of 20 To 50 Years.
2) Person consuming Madya from 3 to 10 years.
3) Person consuming more than 4 drinks on any day or more than 14 drinks
per week. Criteria as per National Institute on Alcohol, Abuse and Alcoholism
(NIAAA). |
|
| ExclusionCriteria |
| Details |
1)Known cases of cholestasis will be excluded.
2)Known cases of Dengue fever, Pyrexia of unknown origin, Systemic lupus
erythematosus, Disseminated intravascular coagulation will be excluded.
3)Known cases of Pancreatitis, Malignancy will be excluded.
4) Patients with organ failure will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the Single cause types of Alcoholism Symptoms in chronic
alcoholic person with special reference to Serum Gamma Glutamyl Transferase
test |
10 Months |
|
|
Secondary Outcome
|
|
|
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)
|
01/01/2025 |
| 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="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
1. Title Assessment of Ekdoshaj types of Madatyaya Lakshanas in Chronic Alcoholic
Person with special reference to Serum Gamma Glutamyl Transferase test.
2.Objectives .PRIMARY OBJECTIVE: To assess and compare the Ekdoshaj types of Madatyaya Lakshanas in chronic
alcoholic person with special reference to Serum Gamma Glutamyl Transferase
test.
3.Methodology 1. APPROPRIATE STUDY DESIGN:
It is an Observational study 2.
STUDY SETTING:
The proposed study will be done in 3 levels. LEVEL 1 (Conceptual) – Ayurvedic literature regarding Madatyaya and its
prakara, lakshanas and modern concept of Chronic Alcoholism & Serum GGT
level will be studied. LEVEL 2 (Observational)- Assessment of Ekdoshaj types of Madatyaya lakshanas
i chroic alcoholic persons and level of Serum GGT level will be done. LEVEL 3 (Analysis) – Analysis of generated data will be performed as Qualitative
and Quantitative data for result
3.Study place:
OPD and IPD of Institutional Hospitals and nearby Hospitals of PCMC area. 4.Study Duration:
18 Months 5.Study Population:
Diagnosed Madatyaya Person fulfilling all inclusion criteria.
6.Sample size:
• 4(pq)/d2
• P- prevalence rate i.e 9.4%=0.094
• q= 1-p=1-0.094=0.906
• Allowable error -10% d=0.1
• Sample size=4(pq)/d square
=4(0.094*0.906)/0.1*0.1
40 persons will be taken for the study. 7.Sampling technique:
Purposive sampling technique will be taken.
8.Method of selection of study subject: A) Inclusion Criteria: 1)Male Persons of Age Group of 20 To 50 Years. 2) Person consuming Madya from 3 to 10 years. 3) Person consuming more than 4 drinks on any day or more than 14 drinks
per week. Criteria as per National Institute on Alcohol, Abuse and Alcoholism
(NIAAA). B)Exclusion Criteria: 1)Known cases of cholestasis will be excluded. 2)Known cases of Dengue fever, Pyrexia of unknown origin, Systemic lupus
erythematosus, Disseminated intravascular coagulation will be excluded. 3)Known cases of Pancreatitis, Malignancy will be excluded.
4) Patients with organ failure will be excluded. |