| CTRI Number |
CTRI/2021/02/031186 [Registered on: 10/02/2021] Trial Registered Prospectively |
| Last Modified On: |
30/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Clinical Study on "Morning Aid" Drink for Alcohol Hangover |
|
Scientific Title of Study
|
An Open Label, Prospective, Randomised, Intra-Comparative, Cross Over Clinical Study to Evaluate the Effectiveness, Safety and Tolerability of “Morning Aid†of Sipwise Beverages Pvt. Ltd. in Alleviating the Symptoms associated with Alcohol Induced Hangover in Adult Subjects |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHC/CNS/060/20 Version no 02 dated 20-Dec-20 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room no 3,
Department of General/Family Medicine
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room no 3,
Department of General/Family Medicine
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room no 3,
Department of General/Family Medicine
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| Sipwise Beverages Private Limited
9 Cosmic Enclave, New Sama Road, Sama,
Vadodara - 390008
Gujarat, India.
|
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|
Primary Sponsor
|
| Name |
Sipwise Beverages Private Limited |
| Address |
9 Cosmic Enclave, New Sama Road, Sama,
Vadodara - 390008
Gujarat, India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Private Limited |
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024. |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Room No 1, Department of General /Family Medicine
180/109, G1 and G2, RR Villa, Rangarajapuram main road, Kodambakkam, Chennai, 600024.
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adults between the ages of 25 and 45 (both ages, all sexes inclusive) who are Social Drinkers |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Morning Aid |
Dose : One bottle
Dosage: One bottle of Morning Aid to be consumed during the 8 drinking episodes as per the administration cycle within the treatment duration of 90 days.
Route of Administration :Oral
Treatment Duration: 8 data points in maximum of 3 months per enrolled subject.
|
| Comparator Agent |
None. Single Arm Study |
None. Single Arm Study |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults between the ages of 25 and 45 (both ages, all sexes inclusive) who are Social Drinker.
2. Subjects must experience atleast two hangovers per month of social drinking.
3. Subject should not have any history/diagnosis of alcoholism/alcoholic substance abuse. (Screening using SMAST)
4. Subjects must have passed the criteria set in the Screening Questionnaire
5. Subjects should be a non-smoker or must smoke ≤10 cigarettes per day.
6. Subjects who are willing to abstain from use of other products not limited to home remedies, soft drinks, mocktails, medications for treating hangover symptoms for the duration of the clinical study.
7. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
8. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
|
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| ExclusionCriteria |
| Details |
1. Subjects with known hypersensitivity to the ingredients of the investigational product
2. Subjects who are on medications not limited to blood thinner that contraindication consumption of alcohol even socially.
3. Subjects with history of liver disease not limited to AFLD, cirrhosis etc.
4. Subjects with history of addiction to alcohol, smoking, and any other drug substance.
5. Subjects with history or diagnosis of psychiatric disorders
6. Subjects with history of uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
7. Subjects with history of seizures
8. Subjects on remission from cancer of any type less than 5 years at the time of screening
9. Subjects who have participated in a clinical study less than 1 month before screening
10. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation.
11. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
12. Subjects, who in the opinion of the Investigator are not eligible for enrolment in the study.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1. Acute Hangover Scale : Total Score - GreaterThan Equal to 18
2. Morning Aid Effectiveness Questionnaire (VAS) : Highest VAS Score |
1. Acute Hangover Scale : After every drinking episode
2. Morning Aid Effectiveness Questionnaire (VAS) : Visit 3 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Subject IP Feedback Questionnaire : Total Score of greater than equal to 20
2. Quality of Sleep VAS – Overall : Improvement of 10%
3. Quality of Sleep VAS – Highest VAS Score
|
1. Subject IP Feedback Questionnaire : Visit 3
2. Quality of Sleep VAS : After every drinking episode
3. Quality of Sleep VAS : After every drinking episode |
|
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Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2021 |
| Date of Study Completion (India) |
10/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Study Design : An Open Label, Prospective, Randomised, Intra-Comparative, Cross Over Clinical Study. Indication : Symptoms associated with Alcohol Induced Hangover Investigator Product : Morning Aid - Anti hangover drink of SipWise Beverages Comparator : None. Screening : Single Blinded Placebo drink is used for screening to rule out bias towards product (placebo effect) Subject Population : Healthy volunteers between the age of 25 and 45 years, who are social drinkers an prone to having hangovers. Number of Subjects : 36 Evaluable Subjects Dose/Dosage : Morning Aid to be consumed per drinking episode. 8 drinking episodes in a study duration of 90 days. Treatment Arms : IntraComparative Model. Assessments
1. Short Michigan Alcohol Screening Test : Prescreening
2. Acute Hangover Scale : Prescreening and after every drinking episode
3. Quality of Sleep : Prescreening and after every drinking episode
4. Morning Aid Effectiveness Questionnaire : Last Visit - Visit 3
5. Subject IP Feedback Questionnaire : Last Visit - Visit 3. Background of the study:
Alcohol Hangover is defined as changes that occur after the consumption and full metabolism of alcohol with sufficient severity to disrupt the performance of daily tasks and responsibilities. High prevalence of social consumption of alcohol across the world calls for a safe and effective product that works to alleviate the undesirable symptoms associated with alcohol induced hangover, Purpose of the study:
Morning Aid is designed with herbal extracts that have proven potential to alleviate symptoms associated with alcohol induced hangover such as headache, nausea etc. This clinical study was designed to evaluate the safety and effectiveness of Morning Aid in reducing alcohol induced hangover symptoms in social drinks, studied in 8 drinking episodes over a period of 90 days
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