Safety, Tolerability and Sensory evaluation of HTUL-031908

Phase 1

Not yet recruiting

• Conditions: Healthy Adult Volunteers

• Registration Number: CTRI/2022/04/041874
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

This is an open label, clinical study to assess the safety, tolerability and sensory evaluation of test product an herbal formulation (HTUL-031908) in total 12 healthy adult volunteers for a period of 7 days. 

All subjects will be evaluated for the tolerability of the intervention at the end of Day 8 as compared to the baseline. All the subjects will be instructed regarding the study procedure and the follow up visits and information regarding the contact person during emergency. All the subjects will be explained regarding the investigations and the sensory evaluation that will be carried out during the study period [Screening and Day 8 (End of the study visit)]. Subjective, objective and sensory parameters will be considered for evaluation to assess the safety, tolerability and sensory evaluation of the test product (HTUL-031908). Assessment will be done at Day 3 and Day 8 (End of study) as compared to the baseline. Study related data from each subject will be collected and recorded in the Case Report Form and will be considered for statistical evaluation. Safety assessment was done by assessing any adverse events reporting done by both the subject and the investigator in the CRFs.



These assessments thus helped to evaluated the safety, tolerability and sensory consequences on the participants before and after the study thus evaluating the safety tolerability and sensory effects of the test product.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-04-13
• Study Start: 2022-04-15

Recruitment & Eligibility

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

Inclusion Criteria

• Each subject must meet all the following criteria to be enrolled in this study: 1) Adult volunteers of either sex with good health.
• 2. Aged between ≥18 to ≤ 60 years.
• 3. Subjects willing to sign informed consent and follow the study procedure and instructions.
• 4. Has not participated in a similar investigation in the past four weeks.
• 5. Women in reproductive age group who will agree to follow an acceptable contraceptive method.

Exclusion Criteria

• Subjects meeting any of the following criteria will be excluded from the study: 1) Subjects with clinically significant cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other systemic condition requiring therapeutic intervention.
• 2. A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the test products.
• 3. Pre-existing systemic disease necessitating long-term medications.
• 4. Genetic and endocrinal disorders.
• 5. Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the safety of HTUL-031908 with number of adverse events observed or reported during the study period in healthy adult volunteers	•Visit 1 Screening/-1 week | •Visit 2 Day1/ screening | •Visit 3 Day 8/ End of study
2. To assess the tolerability and sensory evaluation of HTUL-031908 with total compliance to the study intervention	•Visit 1 Screening/-1 week | •Visit 2 Day1/ screening | •Visit 3 Day 8/ End of study

Secondary Outcome Measures

Name	Time	Method
Not applicable	Not applicable

Trial Locations

Locations (1)

TrialGuna Private Limited; 🇮🇳 Bangalore, KARNATAKA, India

TrialGuna Private Limited

🇮🇳Bangalore, KARNATAKA, India

DR RAJENDRA NARAYAN SHARMA

Principal investigator

9740199006

drrnsclinic@gmail.com