Clinical Study Evaluating the Effect of Bitter Drops on Digestive Comfort Food Cravings and Appetite in Healthy Adult Participants

A Clinical Study to Evaluate the Effect of Bitter Drops on Digestive Comfort Food Cravings and Appetite in Healthy Adults - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/107650

Enrollment

100

Registered

2026-04-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Bitter Drops: Bitter Drops (liquid formulation for oral administration) dose of 25 drops BID, for the total duration of 28 consecutive days and the time of administration will be 10-15

Eligibility

Inclusion criteria

Inclusion criteria: 1 Healthy adult men or women aged 18years to 60 years at the time of signing informed consent 2 Body Mass Index BMI not more than 18.5 kg/m2 3 Regular meal patterns typically consuming at least two main meals per day

Exclusion criteria

Exclusion criteria: 1 Diagnosed clinical eating disorders eg anorexia nervosa bulimia nervosa binge eating disorder 2 Gastrointestinal disorders or prior gastrointestinal surgery 3 Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Change from baseline in digestive comfort parameters assessed using a VAS questionnaire at Day 7 Day 14 Day 21 and Day 28 including Post meal heaviness Bloating Gas or abdominal discomfort Overall digestive comfortTimepoint: Day 7 Day 14 Day 21 and Day 28	—

Secondary

Measure	Time frame
1 Change from baseline in subjective appetite sensations assessed using a VAS questionnaire at Day 7 Day 14 Day 21 and Day 28 including Hunger Fullness Satisfaction Desire to eat thoughts of food 2 Food Cravings Change from baseline in food craving intensity assessed using the VAS questionnaire including overall food cravings specific cravings for sweet fatty salty and spicy foods 3 Safety and Tolerability Incidence and severity of gastrointestinal AEs during the study period including but not limited to nausea vomiting diarrhoea acid reflux and abdominal discomfortTimepoint: Day 7 Day 14 Day 21 and Day 28	—

Measure

Time frame

1 Change from baseline in subjective appetite sensations assessed using a VAS questionnaire at Day 7 Day 14 Day 21 and Day 28 including Hunger Fullness Satisfaction Desire to eat thoughts of food 2 Food Cravings Change from baseline in food craving intensity assessed using the VAS questionnaire including overall food cravings specific cravings for sweet fatty salty and spicy foods 3 Safety and Tolerability Incidence and severity of gastrointestinal AEs during the study period including but not limited to nausea vomiting diarrhoea acid reflux and abdominal discomfortTimepoint: Day 7 Day 14 Day 21 and Day 28

—

Countries

India

Contacts

Public ContactDr Sapna Sharma

Emcure Pharmaceuticals Ltd

Sapna.Sharma@emcure.com8433902431

Outcome results