| CTRI Number |
CTRI/2025/05/087680 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Evaluate the Efficacy and Safety study for PartySmart Soft Chews. |
|
Scientific Title of Study
|
A Double-Blind, Randomized, Crossover, Placebo-Controlled Clinical Study to
Evaluate the Efficacy and Safety of PartySmart Soft Chews |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/011/2025 V 1.0, Dated: 16 thApril 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Dinesh |
| Designation |
General Physician |
| Affiliation |
Ayuryogamruth Ayurvedic Multi-speciality Hospital |
| Address |
No.28,34th Cross, 6th Main J.P, Nagar1st phase
Bangalore
KARNATAKA
560078
India |
| Phone |
9886125229 |
| Fax |
|
| Email |
bhaktha.dinesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumawat |
| Designation |
Head Of Medical Services and Clinical Development |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549904 |
| Fax |
|
| Email |
rajesh.kumawat@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Manager- Clinical Operations |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company. Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road. Bengaluru, Karnataka, India.562 162, India |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road,Makali, Bengaluru 562 162, 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 S Dinesh |
Ayuryogamruth Ayurvedic Multi-speciality Hospital |
No.28,34th Cross, 6th Main J.P, Nagar1st phase
Bangalore
KARNATAKA |
9886125229
bhaktha.dinesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adult participants aged between 20-50 years, with history of social alcohol
consumption and Hangover Symptom Score (HSS) 5. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Partysmart Soft chews, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 3034.73(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: -2 PartySmart Active/ Placebo chews.
25 participants will receive IP 30 minutes before alcohol consumption & 25 participants will receive IP after alcohol consumption.
| | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Partysmart placebo soft chews, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 3034.73(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: 2 PartySmart Active/ Placebo chews.
25 participants will receive IP 30 minutes before alcohol consumption & 25 participants will receive IP after alcohol consumption.
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Day(s) |
| Age To |
50.00 Day(s) |
| Gender |
Both |
| Details |
1.Male and female participants aged between 20 to 50 years, with BMI 18.5 to 25 kg per m2.
2.Participants with previous history of social alcohol consumption and hangover symptom score (HSS) greater than 5.
3.Participants who used to drink alcohol regularly or more than once in a month(social drinking, but not alcohol abuse) and are willing and able to comply with the alcohol consumption, blood withdrawal requirements and overnight stay as per the study requirements.
4.Participants judged by the Investigator to be in general good health based on medical history and laboratory investigations.
5.Participants understand the study procedures and sign informed consent forms to participate in the study.
6.Women of child bearing potential and men with partners of child bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy.
Note: A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria
a. Has not undergone a hysterectomy or bilateral oophorectomy or
b. Has not attained menopause (Women not menstruating for at least 12 consecutive months).
7. Male participants who are willing to refrain from donating sperm from first admission to the study until 90 days after the study completion.
|
|
| ExclusionCriteria |
| Details |
1.Excessive drinking or alcohol intake in the past one week.
2.Participants who have participated in a any other clinical trial within last 1 month.
3.Known history of alcohol abuse or dependency or drug abuse that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions or study procedures.
4. Any other conditions (physical, psychological, social or uncontrolled dietary measures) that can interfere with the participant’s compliance to the study in the opinion of the Investigator.
5. Participantive sleep duration of less than 3 hours in the night before every study period.
6. Participants taking any dietary supplements or medications within last 1month that may affect alcohol metabolism as per Investigator’s discreation.
7. Participants with known clinically significant disorders like Alcohol metabolism disorders, diabetes, hypertension, cholelithiasis, pancreatitis, gout, active tuberculosis, Gastrointestinal bleeding, kidney or liver disease (hepatitis B or C carriers, alcoholic Liver disease, etc.), heart, lung, gastrointestinal, nervous system disease or any other chronic disorder that can interfere with the study conduct in the opinion of the Investigator.
8. Participants with known history or present condition of allergic response to any of the ingredients in the investigational product.
9. Pregnant as assessed by UPT and History of Amenorrhea and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary efficacy outcome: •Blood alcohol and acetaldehyde levels
Secondary efficacy outcomes:
-Assessment of Acute Hangover Scale (AHS)
-Acute Hangover Severity Scale (AHSS)
- Clinical assessment of “Alcohol Hangover Symptoms”
|
Primary efficacy outcome time points:
Pre alcohol,0hr,0.25hr,0.5hr,1 hr,2hr,4hr,6hr and 15hr.
Secondary efficacy outcome time points:
15th hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
-Assessment of Acute Hangover Scale (AHS)
-Acute Hangover Severity Scale (AHSS)
-Clinical assessment of Alcohol Hangover Symptoms”
-Safety evaluation through Laboratory Investigations.
-Incidence of adverse events
|
Day0, Day 1 & Day 2 15th Hour. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| Date of Study Completion (India) |
Date Missing |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
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 formulation Partysmart soft chews on alcohol hangover, in correlation with Blood levels of alcohol and acetaldehyde in normal healthy Volunteer. |