Evaluation of safety, tolerability of Septilin Syrup in healthy people.

Phase 1

Not yet recruiting

• Conditions: Septilin, a polyherbal formulation, is recommended for the treatment and management of various infections, and to prevent their recurrence as it has immunomodulatory action

• Registration Number: CTRI/2022/04/041811
• Lead Sponsor: Himalaya Wellness Company

Brief Summary

The neonatal period and infancy are very important periods in the life of an individual. The process of birth suddenly requires the infant to acclimatise and accommodate to the varying physiological and environmental factors necessary for independent functioning and existence. This is the period during which the new born achieves developmental maturity provided nutrition, digestion, metabolism and general care are satisfactory. Any slight disturbances in any of the systems especially the disturbances of the immune system both in children and adults poses difficulty in fighting against any type of systemic infections. This needs more attention and care in both children and adults in order to treat these symptoms related to the systemic infection effectively. Herbal remedies could be of immense benefit to mankind as they possess nature’s own healing powers than many synthetic drugs. Himalaya has committed itself to discover/develop new drugs from traditional Ayurvedic/herbal remedies and folklores. Himalaya has developed a novel polyherbal herbal syrup termed as Septilin Syrup with potent herbal actives. Septilin Syrup subjected to Safety, tolerability and sensory evaluation of Septilin Syrup in healthy adult and pediatric volunteers.

This is an open-label, single-arm, two-period clinical study. Total 12 healthy adult subjects aged between ≥ 18 years to ≤ 50 and 12 healthy pediatric subjects aged between ≥ 2 years to ≤ 12 years will be initiated with the informed consent process followed by screening and enrollment after they fulfill the inclusion criteria. All eligible adult subjects will receive 10 ml Septilin syrup thrice daily oral.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-20
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adult population: 1.
• Healthy adult subjects of either sex aged between ≥ 18 to ≤ 50 years.
• Subjects willing to refrain taking any other similar medication during the study period 3.
• Adult subjects who have not participated in this kind of trial in the past 4 weeks 4.
• Adult subjects willing to sign informed consent and follow the study procedure.
• Pediatric Population: 1.
• Healthy male and female pediatric subjects aged between ≥2 years to ≤12 years.
• Parents/Guardians/Caregiver related to pediatric subjects < 7 years willing to give informed consent for his/her child to participate in the study.
• Pediatric subjects aged > 7 years of age willing to provide oral consent for his/her participation in the study along with parents/guardians/caregiver consent (Refer protocol section 11.4, Informed Consent Process) 4.
• Pediatric Subjects willing to refrain taking any other similar medication during the study period 5.
• Pediatric subjects who have not participated in this kind of trial in the past 4 weeks.
• Parents/ Guardians/ Caregivers of the pediatric subjects willing to sign informed consent/assent (as applicable) and follow the study procedure.

Exclusion Criteria

• Subjects with clinically significant serious cardiovascular, respiratory, cerebrovascular, hepatic, renal disease, endocrinal, congenital or any other disorder.
• A known history or present condition of allergic response to the study products its components or ingredients in the investigational product.
• Pre-existing systemic disease necessitating long-term medications.
• Subjects who refused to sign informed consent.
• 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 events during the study period.	7 days

Secondary Outcome Measures

Name	Time	Method
Overall compliance to the study medication	7 days

Trial Locations

Locations (1)

Xplora Clincal Research Services; 🇮🇳 Bangalore, KARNATAKA, India

Xplora Clincal Research Services

🇮🇳Bangalore, KARNATAKA, India

Dr Dinesh S

Principal investigator

9886125229

bhaktha.dinesh@gmail.com