A clinical Study to Check Effect & Safety of Chamomile Valerian Herbal Tea on Sleep Improvement and Reducing Anxiety in Healthy Humans.

Not yet recruiting

• Conditions: Sleep disturbance and anxiety otherwise healthy

• Registration Number: CTRI/2025/06/088445
• Lead Sponsor: Luxmi Tea Co. Private Limited

Brief Summary

Thisis a randomized, double blind, single centric, placebo controlled, two armclinical study. A total of 32 subjects, including approx. 10 percent dropoutwill be screened and randomly assigned in 1 is to 1 ratio to Chamomile ValerianHerbal Tea or Placebo group that is 16 subjects in each group. The duration ofeach subject’s participation in the study will be of 46 days and the treatmentperiod is 45 days (IP will be administered from Day 1 to Day 45). Efficacy and safety assessments will be done at boththe visits. Subjects will be asked to bring their unused IP and AE diariesalong with sleep diaries at the end of study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-06
• Study Start: 2025-06-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Males or females above the age of 18 years who experience anxiety and have difficulty initiating and or maintaining sleep.
• Subject or the subject’s legally authorized representative willing to give written informed consent.
• Subjects willing to come for visits at the site as per protocol.
• Subject should not be on Antidepressant or any medication for anxiety.
• Subject should not be on sleep medication.
• Subject should not be consuming any dietary supplements consisting Chamomile or Valerian till the end of study.

Exclusion Criteria

• Pregnant, lactating women.
• Subjects consuming sedative hypnotics, benzodiazepines, cyclopyrrolones, imidazopyridines, barbiturates, etc.
• Severe psychiatric disorders.
• Restless legs or leg cramps that influence sleep and everyday life.
• Conditions that prevent sleep through the symptoms that they produce (pain, nightly coughs, etc.).
• Breathing problems (asthma, severe snoring, sleep apnea, etc).
• Subjects with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy.
• Irregular work hours, including shift work at night.
• Subject consuming alcohol.
• High caffeine intake (More than 10 cups per day) or equivalent caffeine intake from other caffeinated drinks example tea, energy drinks.
• Contraindication or allergy to any substance in the investigational product.
• Currently, or within the past 30 days, enrolled in a different clinical investigation.
• Unable or unwilling to provide written informed consent for participation in the study.
• Subjects suffering from chronic illness or any other condition that, in the opinion of the investigator, may compromise the safety and compliance of the participant or preclude the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of Sleep: Total Sleep Time and the Number of Awakenings Post Sleep Onset using Sleep Diary , Evaluation of Quality of Sleep through Sleep Quality Scale (SQS) score, Evaluation of Anxiety: Hamilton Anxiety Rating Scale (HAM-A) score.	Screening and Baseline (Day 0) and end of study (Day 46)

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of Day Functionality through Stanford Sleepiness Scale (SSS) score	2. Evaluation of Quality of Life through World Health Organization-Five Well-Being Index (WHO-5)

Trial Locations

Locations (1)

Sunad Ayurved; 🇮🇳 Pune, MAHARASHTRA, India

Sunad Ayurved

🇮🇳Pune, MAHARASHTRA, India

Dr Vidyadhar Kumbhar

Principal investigator

9960075536

dr.vidyadhar24@gmail.com