| CTRI Number |
CTRI/2021/03/032236 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
22/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect PartySmart Variants in alcohol subjects. |
|
Scientific Title of Study
|
A double-blind randomised placebo-controlled study followed by an Open-label extension, comparative clinical study to evaluate the effect of PartySmart variants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/MSCD/PP/010/2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Faridha Khanum Abbasi |
| Designation |
Consultant cum Technical Director |
| Affiliation |
Healing Earth Multi-specialty Ayurveda hospital |
| Address |
Healing Earth Multi-specialty Ayurveda hospital
#149, Sector-5,HSR Ring Road
HSR Layout Bangalore.
Bangalore
KARNATAKA
560034
India |
| Phone |
9886329022 |
| Fax |
|
| Email |
drfaridakhanum@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srikrishna |
| Designation |
Research Scientist |
| Affiliation |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company, Room No 301,3rd Floor Medical Services & Clinical Development,Reserach and Development Makali,Tumkur Road,
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.srikrishna@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan |
| Designation |
Clinical Trial Manager |
| Affiliation |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company, Room No 301,3rd Floor Medical Services & Clinical Development, Reserach and Development Makali,Tumkur Road,
Bangalore Rural
KARNATAKA
562162
India |
| Phone |
|
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company. Makali, Makali Aluru Main Rd, Opp JCB, Bengaluru, Karnataka 562162. |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company. Makali, Makali Aluru Main Rd, Opp JCB, Bengaluru, Karnataka 562162. |
| 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 Faridha Khanum Abbasi |
Healing Earth Multi-specialty Ayurveda hospital |
Room No 1 , Ground Floor.
Healing Earth Multi-specialty Ayurveda hospital
#149, Sector-5,HSR Ring Road
HSR Layout Bangalore-560034
Bangalore
KARNATAKA |
9886329022
drfaridakhanum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PartySmart Capsules |
Arm A: PartySmart Capsule– Subject will receive 1 capsule before the beginning of the alcohol consumption between 30 minutes to maximum 1 hour.
Arm B: PartySmart Capsule – Subject will receive 1 capsule immediate after completion of Alcohol consumption (Last sip)
|
| Intervention |
PartySmart Chews Active/Placebo |
Arm A: Active/Placebo Chews – Subject will receive two soft chews before the beginning of the alcohol consumption between 30 minutes to maximum 1 hour.
Arm B: Active/Placebo Chews – Subject will receive two soft chews immediate after completion of Alcohol consumption (Last sip)
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1.Males aged between 20-45 years, weighing more than 45 kgs
2Subject who used to drink alcohol regularly (social drink not alcohol abuse) and is willing and able to comply with the alcohol consumption requirements and overnight stay as per the study requirements
3.Subjects judged by the Investigator to be in general good health based on medical history.
4.Subject understands the study procedures and signs the consent forms providing informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Subject suspected for drug or alcohol abuse
2.A medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
3.Subjective sleep duration of less than 3 hours in the night before the test
4.Caffeine, nicotine or alcohol on the day (from midnight) of the test
5.Use of psycho-active drugs during the past 30 days or any treatment that might interfere with the evaluation of the test drug
6.Any drug known to interact with benzodiazepines and related drugs, e.g. antiepileptics, antihistaminics, muscle relaxant drugs, antihypertensive drugs, drugs inhibiting cytochrome P450
7.Any clinically significant disorder that might interfere with his/her participation in this study and the evaluation of the efficacy or safety of the test drug (e.g. renal insufficiency, hepatic or metabolic dysfunction, cardiovascular disease, neurological and or psychiatric disorder etc.)
8.Known hypersensitivity to any of the ingredients of the study drugs
9.Participation in any other clinical trial within the past 30 days
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Change in the blood alcohol and acetaldehyde levels
2.Clinical symptoms related to alcohol consumption
3. Assessment of Alcohol Hangover Questionnaire (AHQ)
|
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of adverse effects.
|
12 Hours |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
30/03/2021 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Alcohol
hangover develops when the blood alcohol concentration (BAC) returns to zero
and is characterized by a feeling of general misery that may last for more than
24 hours. Several factors are known to be involved including acetaldehyde
accumulation, changes in immune system and glucose metabolism, dehydration.
Hangover is suggested to be early stage of alcohol withdrawal. The rational of study to evaluate the effect of
polyherbal formulations PartySmart variants on alcohol hangover, in correlation
with Blood levels of alcohol and acetaldehyde in normal healthy Volunteers |