| CTRI Number |
CTRI/2017/09/009831 [Registered on: 19/09/2017] Trial Registered Prospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the efficacy and safety of DOTSHOT in the treatment of Hangover of Alcohol |
|
Scientific Title of Study
|
A Randomized Double Blind placebo controlled parallel clinical study to evaluate the efficacy and safety of DOTSHOT in the treatment of Hangover due to alcohol intoxication |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBIO/CR/PEPL/0531/75 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Indu M Raja |
| Designation |
Principal Investigator |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore
KARNATAKA
560 097
India |
| Phone |
|
| Fax |
|
| Email |
pi.mail@icbiocro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha s |
| Designation |
Director operations |
| Affiliation |
ICBio Clinical Research Pvt. Ltd. |
| Address |
#16 & 18, ICBio Tower, Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore
KARNATAKA
560 097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| K. Patel phyto Extraction Pvt. Ltd
A-101, Alaknanda, Anna SahebVartak Marg,
Borivali (W), Mumbai 400092, MH, India
|
|
|
Primary Sponsor
|
| Name |
K Patel phyto Extraction Pvt Ltd |
| Address |
A-101, Alaknanda, Anna SahebVartak Marg,
Borivali (W), Mumbai 400092, MH, India.
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Indu M Raja |
ICBio Clinical Research Pvt. Ltd. |
#16 & 18, ICBio Tower, Yelahanka Main Road,
Chikkabettahalli, Vidyaranyapura,
Bangalore
KARNATAKA |
80-23641042
pi.mail@icbiocro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri venkateshwara Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hangover due to alcohol consumption for occasional drinker |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DOTSHOT oral liquid |
Curcumin extract of turmeric
Oral liquid
70 ml of Health drink of DOTSHOT 30 minutes after last drink. |
| Comparator Agent |
Placebo(without active constituents) |
Placebo (without active constituents but it contains natural and artificial sugar, water, preservatives, anti-oxidants, acidity stabilizers etc)
70 ml of Health drink of PLACEBO 30 minutes after last drink |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Michigan Alcoholism Screening Test (MAST): more than 2 to 5. -
2. Willing to provide written informed consent for participation in the study and adhere to the protocol requirements
|
|
| ExclusionCriteria |
| Details |
1. A medical history of significant hypersensitivity or allergic reaction to turmeric or related products.
2. Volunteers have history of alcohol toxicity like liver cirrhosis, neurological disease, peptic disease, diabetes, drug abuse.
3. Volunteers have undergone any concomitant medications like antibiotics, anticoagulants, tricyclic antidepressant, cardiovascular medication, sedative, hypnotics. Prior to 14 days.
4. History of bile duct obstruction or Cysts of the common bile duct
5. If they have hypersensitivity for alcohol ingestion.
6. If they have habit of smoking or tobacco chewing
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Endpoints
1. Assessment of changes in Biochemical Evaluation from screening to end of the treatment for hangover effects.
2. The Biochemical parameters includes:-
a. ALDH (Acetaldehyde Dehydrogenase): Baseline, after 0, 2 hours and 10 hours of the formulation.
b. Blood Aldehyde: Baseline, after 0, 2 hours and 10 hours of the formulation.
c. Blood Alcohol: Baseline, after 0, 2 hours and 10 hours of the formulation.
d. ALT, AST and ALP (baseline, 2 and 10 hours of formulation)
|
From Baseline To End of Treatment
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Assessment of Changes in the Behaviour from screening to end of the treatment for hangover effects.
2. Behaviour study based questions:
a. Questionnaire to ask to understand the level of hangover.
b. Walk test on drawn single line on the floor (15 meters) to understand the level of hangover.
c. Incidence and rate of adverse events
|
From Baseline To End of Treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/09/2017 |
| Date of Study Completion (India) |
19/09/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized Double Blind Placebo controlled parallel clinical study to evaluate the Efficacy of Healthdrink DotShot 70 ml in the treatment of Hangover Due to alcohol Intoxication
Total 30 male subject will be enrolled in the study
In house study
Duration of the study will not exceed 10 days
To compare the safety and efficacy of Health drink DotShot 125 mg curcumin/ 70 ml and placebo in the treatment of alcohol induced Hang over
|