Evaluation of safety and tolerability of HASG-072009 Capsules in healthy people

Not yet recruiting

• Conditions: Healthy adult volunteers

• Registration Number: CTRI/2022/06/043369
• Lead Sponsor: Himalaya Wellness Company

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 and thereby reduce your focusing ability

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 a focused mind to carry out the normal daily living activities, a novel polyherbal formulation HASG-072009 has been formulated to combat the global systemic visceral impact and bring about a focused 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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-06-20
• Study Start: 2022-06-30

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, hepatic, renal disease, congenital or any other disorder.
• 2.Subject with abnormal lab values detected at the time of screening shall be excluded.
• 3.A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the investigational product.
• 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
Occurrence of any adverse or serious adverse	7 days
events during the study period.	7 days

Secondary Outcome Measures

Name	Time	Method
overall compliance of study medication	7 days

Trial Locations

Locations (1)

Xplora Clinical Research services; 🇮🇳 Bangalore, KARNATAKA, India

Xplora Clinical Research services

🇮🇳Bangalore, KARNATAKA, India

DrDinesh

Principal investigator

9886125229

bhaktha.dinesh@gmail.com