| CTRI Number |
CTRI/2019/10/021812 [Registered on: 29/10/2019] Trial Registered Prospectively |
| Last Modified On: |
19/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the efficacy and safety of PARTY ZEST AHO liquid for the prevention of hangover due to alcohol intoxication |
|
Scientific Title of Study
|
A randomized double blind placebo controlled parallel clinical study to evaluate the efficacy and safety of PARTY ZESTAHO liquid Curcumin for the prevention of hangover due to alcohol intoxication |
| Trial Acronym |
ICBio-CR-ZNPL-0906-97 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio-CR-ZNPL-0906-97 version 01 dated 06 Sep 2019 |
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 and 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli
Vidyaranyapura
Bangalore 560 097 India
Bangalore
KARNATAKA
560097
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 and 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore 560 097 India
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| 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 and 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli Vidyaranyapura
Bangalore 560 097 India
Bangalore
KARNATAKA
560097
India |
| Phone |
09900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Zystus Nutraceuticals Pvt Ltd
Gajularamaram Village
Pragathi Nagar Kukatpally
Hyderabad 500 072
|
|
|
Primary Sponsor
|
| Name |
Zystus Nutraceuticals Pvt Ltd |
| Address |
Plot No 121-122 Road No 6
ALEAP Industrial Estate
Gajularamaram Village
Pragathi Nagar Kukatpally
Hyderabad 500 072
|
| 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 Harisha S |
ICBio Clinical Research Pvt Ltd |
16 and 18 ICBio Tower Yelahanka Main Road Chikkabettahalli Vidyaranyapura Bangalore 560 097 India
Bangalore
KARNATAKA |
09900111997
harish@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
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hangover |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PARTY ZEST AHO-liquid 75 ml 275 mg of herbal actives per drinkoral liquid |
Dosing will be done before initiation of drinking (30 min) for 30 subjects (either test or placebo based on randomization) and after completion of drinking session (30 min) for 30 subjects (either test or placebo based on randomization) Dosing will be done in night around 8 PM |
| Comparator Agent |
PARTY ZEST AHO-Placebo 75 ml (without active constituents) oral liquid |
Dosing will be done before initiation of drinking for 30 subjects and after completion of drinking session for 30 subjects Dosing will be done in night around 8 PM |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1 Healthy male
2 Age 25-45 years have the willingness to
undergo alcohol drinking
3 Michigan Alcoholism Screening Test more than
2 to 5 (Attachment no.1)
4 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 |
Assessment of changes in Biochemical Evaluation of the prevention for hangover effects for both the groups
The Biochemical parameters includes
1.ALDH (Acetaldehyde Dehydrogenase) Baseline after 0, 2 hours and 10 hours of the formulation
2.Blood Aldehyde Baseline, after 0, 2 hours and 10 hours of the formulation
3.Blood Alcohol Baseline, after 0, 2 hours and 10 hours of the formulation.
4.ALT, AST and ALP (baseline, 2 and 10 hours of formulation)
|
From baseline to end of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Changes in the Behaviour of the prevention for hangover effects for both the groups
Behaviour study based questions
1 Questionnaire to ask to understand the level of hangover (Attachment no. 2)
2 Walk test on drawn single line on the floor (15 meters) to understand the level of hangover (Attachment no. 3)
Incidence and rate of adverse events
|
From baseline to end of treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2019 |
| Date of Study Completion (India) |
23/11/2019 |
| 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
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A randomized double blind placebo controlled parallel clinical study to evaluate the efficacy and safety of PARTY ZEST AHO-liquid (Curcumin)for the prevention of hangover due to alcohol intoxication.
Total Sixty(60) Healthy male subjects was enrolled in the study In house study Duration of study was not exceed 10 days. To Compare the safety and efficacy of Health drink PARTY ZESTAHO-liquid 275 mg of herbal actives per drink and PLACEBO for the prevention of alcohol induced hangover. |