| CTRI Number |
CTRI/2023/03/051001 [Registered on: 23/03/2023] Trial Registered Prospectively |
| Last Modified On: |
22/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of Safety and Tolerability of HOAW-062101 in Healthy Adults |
|
Scientific Title of Study
|
An Open-Label, Single-Arm Clinical Study to evaluate the Safety and Tolerability of HOAW-062101 in Healthy Adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh S |
| Designation |
Consultant pulmonologist |
| Affiliation |
Xplora Clinical Research Services Pvt. Ltd |
| Address |
Xplora Clinical Research Services Pvt. Ltd, Room No.01, Division Clinical Research, Door no. 252, 13th Cross Wilson Garden, Bangalore
Bangalore
KARNATAKA
560027
India |
| Phone |
|
| Fax |
|
| Email |
bhaktha.dinesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Soorya Narayan |
| 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
Bangalore
KARNATAKA
562162
India |
| Phone |
08067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Kavitha R |
| Designation |
Senior Clinical Research Associate |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd Floor Medical Services and Clinical Development(R&D), Makali Tumkur Road, Bangalore
Bangalore
KARNATAKA
562162
India |
| Phone |
08067547231 |
| Fax |
|
| Email |
kavitha.rangaiah@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
Bangalore
|
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Room No. 301, 3rd Floor, Medical Services and Clinical Development(R&D), Makali Tumkur Road |
| 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 Dinesh |
Xplora Clinical Research Pvt.Ltd |
Room No 1, Ground Floor, Division Clinical Research, Door No 252, 13th Cross Wilson garden, Bangalore
Bangalore
KARNATAKA |
9886125229
bhaktha.dinesh@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 adult volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Ashwagandha, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 670(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Ashwagandha single arm study |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult subjects of either sex aged between ≥18 to ≤50 years.
2. Subjects willing to sign informed consent and follow the study procedure.
3. Has not participated in a similar investigation in the past four weeks.
4. Subjects willing to refrain taking any other similar supplements during the study period
|
|
| ExclusionCriteria |
| Details |
1.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other disorder.
2.Subjects with any abnormal lab values detected at screening shall be excluded.
3.A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational products (IP).
4.Pre-existing systemic disease necessitating long-term medications.
5.Genetic and endocrinal disorders.
6.Subjects who refused to sign informed consent.
7.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of any adverse or serious adverse events reported or observed during the study period for 7 days |
Incidence of any adverse or serious adverse events reported or observed during the study period for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall compliance of the subject to the study medication |
7 days |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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 |
|
Date of First Enrollment (India)
|
28/03/2023 |
| 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
|
In an era of
stress driven daily living activities carried out by schoolers to the working,
elderly, and retired individuals; a healthy, calm and enjoying way of carrying
out and making to carry out the daily living activities have been completely
compromised with enhanced self-deceitful, suspicious approach towards
individual self and human connections. This in turn has led and is still
leading every individual to completely succumb to the global systemic impact of
physical, emotional, intellectual stress thereby altering the normal
physiological overall growth response and progressive pathological response to
the stressful stimuli. In addition to the above, the foremost etiology for this
stress driven activities could be attributed to the fast-track mode of daily
living in terms of diet and lifestyle. This indeed has accelerated the
progression of various underlying pathological processes and thereby leading
every human to succumb for various psychosomatic disorders. As a
ground-breaking reality, adhering to the ancient principles and practices of
healthy dietary and lifestyle guidelines seems to be the only conscious driven
therapeutic measures to combat the detrimental impact. In an attempt of
incorporating the same and keeping the global systemic impact of stress and the
acquired restless state of mind in carrying out the very normal daily living
activities, a novel polyherbal formulation HOAW-062101 has been formulated to
combat the global systemic visceral impact and bring about a relaxed state of
mind in carrying out every daily living activities. This study is planned to
evaluate the safety and tolerability of the novel formulation in healthy adult
individuals. |