| CTRI Number |
CTRI/2023/12/060476 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety Evaluation of HORS-051511 in Healthy Adults |
|
Scientific Title of Study
|
An Open-Label, Single Arm, Clinical Study to Evaluate the Safety of HORS-051511 in Healthy Adults |
| Trial Acronym |
NIIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/FF/039/2023, Version No 1.0, Dated 06/11/2023. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra Narayan Sharma |
| Designation |
Internal medicine |
| Affiliation |
TrialGuna Private Limited |
| Address |
TrialGuna Private Limited
467, 1 st Main, 4 th Cross Royal County Layout
JP Nagar 8 th Phase Bangalore
Bangalore
KARNATAKA
560083
India |
| Phone |
97401999006 |
| Fax |
|
| Email |
drrnsclinic@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soorya Narayan |
| Designation |
Manager Clinical Operations |
| Affiliation |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Veeresh M Chakkadi |
| Designation |
Clinical Research Associate |
| Affiliation |
Himalaya Wellness Company |
| Address |
Himalaya Wellness Company
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
08310218654 |
| Fax |
|
| Email |
veeresh.chakkadi@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, Bangalore |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company (HWC) |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development (R&D), Makali Tumkur Road, Bangalore – 562 162 |
| 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 Rajendra Narayan Sharma |
TrialGuna Private Limited |
#467, 1 st Main, 4 th Cross Royal County Layout,
JP Nagar 8 th Phase, Bangalore 560083
Bangalore
KARNATAKA |
9740199006
drrnsclinic@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 |
Moderate to vigorous physical activities/exercising healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Himalaya ORSL |
1 pack per day 200ml tetra pack
(before/during/after moderate to vigorous physical activities/exercise) for a duration of 7 days. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy adult subjects, both men and women within age group of 18 to 45 years.
2.Subjects willing to sign an informed consent document.
3.Subjects willing to adhere to protocol requirements throughout the study period.
4.Subjects who have not participated in any clinical study in the past 30 days.
5.Subjects who are willing to do moderate and vigorous physical activities at least 4 times a week as reported by the subjects. (Appendix I)
|
|
| ExclusionCriteria |
| Details |
1.Women who are pregnant, nursing, or planning a pregnancy during study entry and through the duration of the study.
2.Subjects with known allergies to any of the ingredients of the test product.
3.Subject with clinically significant abnormal lab values detected at the time of screening as determined by the investigator.
4.Subject who had a history of hypersensitivity to any packaged rehydration beverage.
5.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other disorder as determined by the investigator.
6.Subjects with clinically significant pre-existing systemic disease necessitating long-term medications as determined by the investigator.
7.Subjects not willing to refrain from taking any other similar supplements during the study period.
8.Subjects not willing to abstain from excessive intake of recreational products like tobacco/pan chewing, smoking, alcohol and any other as determined by the investigator during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of safety of HORS-051511 in healthy adults by the following assessments:
1.General Physical Examinations
2.Laboratory Examinations. |
1 Day and 7 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse events (AE): AEs/SAEs will be continuously monitored throughout the duration of the study |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
Final Enrollment numbers achieved (Total)= "12"
Final Enrollment numbers achieved (India)="12" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/12/2023 |
| Date of Study Completion (India) |
03/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
PROTOCOL TITLE: An Open-Label, Single Arm, Clinical Study to Evaluate the Safety of HORS-051511 in Healthy Adults. PROTOCOL NUMBER/VERSION: HWC/MSCD/FF/039/2023, Version No: 1.0, Dated 06th November 2023.
This is a single-arm, open-label clinical trial designed to evaluate the safety of HORS-051511, which is available in three flavors (Apple, Pomegranate, and Orange), specifically in healthy adults. The study aims to enroll a total of 12 subjects, with all participants in a single arm. The primary objective is to assess the safety of the test product during a seven-day usage period. The study will involve assessments on day 1 (baseline) and day 7 (+1 day) to monitor various aspects, including general physical health, laboratory values, adverse events, and medication use. The test product, provided by Himalaya Wellness Company, is a functional beverage comprising essential electrolytes, vitamins, and natural fruit ingredients, with the purpose of replenishing electrolytes, providing energy, combating fatigue, reducing oxidative stress, and aiding in rehydration. Participation in the study is voluntary, and subjects will be selected based on eligibility criteria. The study results will contribute to ensuring the product’s safety for consumers and may support further product development
|