Evaluation of Safety and Tolerability of HOAW-062101 in Healthy Adults

Phase 1

Not yet recruiting

• Conditions: healthy adult volunteers

• Registration Number: CTRI/2023/03/051001
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

In an era ofstress driven daily living activities carried out by schoolers to the working,elderly, and retired individuals; a healthy, calm and enjoying way of carryingout and making to carry out the daily living activities have been completelycompromised with enhanced self-deceitful, suspicious approach towardsindividual self and human connections. This in turn has led and is stillleading every individual to completely succumb to the global systemic impact ofphysical, emotional, intellectual stress thereby altering the normalphysiological overall growth response and progressive pathological response tothe stressful stimuli. In addition to the above, the foremost etiology for thisstress driven activities could be attributed to the fast-track mode of dailyliving in terms of diet and lifestyle. This indeed has accelerated theprogression of various underlying pathological processes and thereby leadingevery human to succumb for various psychosomatic disorders. As aground-breaking reality, adhering to the ancient principles and practices ofhealthy dietary and lifestyle guidelines seems to be the only conscious driventherapeutic measures to combat the detrimental impact. In an attempt ofincorporating the same and keeping the global systemic impact of stress and theacquired restless state of mind in carrying out the very normal daily livingactivities, a novel polyherbal formulation HOAW-062101 has been formulated tocombat the global systemic visceral impact and bring about a relaxed state ofmind in carrying out every daily living activities. This study is planned toevaluate the safety and tolerability of the novel formulation in healthy adultindividuals.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-03-22
• Study Start: 2023-03-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Healthy adult subjects of either sex aged between ≥18 to ≤50 years.
• Subjects willing to sign informed consent and follow the study procedure.
• Has not participated in a similar investigation in the past four weeks.
• Subjects willing to refrain taking any other similar supplements during the study period.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Overall compliance of the subject to the study medication	7 days

Trial Locations

Locations (1)

Xplora Clinical Research Pvt.Ltd; 🇮🇳 Bangalore, KARNATAKA, India

Xplora Clinical Research Pvt.Ltd

🇮🇳Bangalore, KARNATAKA, India

Dr Dinesh

Principal investigator

9886125229

bhaktha.dinesh@gmail.com