Actively Recruiting
Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
Led by Valenta Pharm JSC · Updated on 2025-07-11
300
Participants Needed
17
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the efficacy, safety, and tolerability of the drug 4-MUST at various doses compared to placebo in patients with chronic cholecystitis and biliary dyskinesia
CONDITIONS
Official Title
Efficacy, Safety, and Tolerability of 4-MUST Tablets in Chronic Cholecystitis and Biliary Dyskinesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18-70 years
- Diagnosed with chronic cholecystitis or dyskinesia of the bile duct or gallbladder
- Experiencing upper abdominal pain or discomfort plus at least one symptom such as heartburn, belching, nausea, bloating, stomach rumbling, flatulence, constipation, or diarrhea
- Upper abdominal pain severity of 40 mm or more on the Visual Analog Scale during the past week
- Gastrointestinal symptoms severity score of at least 30 points according to the Gastrointestinal Symptom Rating Scale questionnaire
- Women must be sexually abstinent or using effective contraception for at least 8 weeks before and 3 weeks after the study, or have documented infertility or non-childbearing status; men must use barrier contraception or have documented infertility
- Signed and dated informed consent form
You will not qualify if you...
- Presence of peptic ulcer disease, duodenal ulcer, or erosive GERD
- Toxic megacolon or paralytic ileus
- Gilbert's syndrome or abdominal adhesion disease
- Blood in stool, unexplained weight loss, fever, or anemia
- Inflammatory or erosive gastrointestinal diseases such as irritable bowel syndrome, ulcerative colitis, Crohn's disease
- Any oncological diseases of the gastrointestinal tract, current or past
- History of gastrointestinal surgery except appendectomy
- Use of prohibited medications within 3 days before randomization
- History of mental illnesses
- Chronic heart failure IIb-III stages or angina pectoris III-IV classes
- Chronic kidney disease stage IIIa-V
- Liver failure or significant liver enzyme abnormalities
- HIV, syphilis, or viral hepatitis B or C, current or past
- Lactose intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome
- Liver cirrhosis
- Hypersensitivity to 4-MUST or its ingredients
- Severe, unstable, or life-threatening diseases
- Uncontrolled diabetes mellitus
- Systemic connective tissue or autoimmune diseases
- Need for surgery, endovascular treatment, or hemodialysis
- Epilepsy or seizures of unknown cause
- Alcoholism, substance abuse, or drug addiction
- Uncorrected electrolyte imbalances
- Surgery within 6 months before screening
- Pregnancy, lactation, or planning pregnancy within 6 months
- Requirement for prohibited concomitant therapy
- Participation in another clinical trial within 3 months before screening
- Lack of willingness to cooperate
- Other conditions judged by the investigator as incompatible with study participation
- Incorrect enrollment or failure to meet criteria at randomization
- Ineffective therapy by visit 3 (day 15����������)
- Non-compliance with medication intake
- Requirement for prohibited concomitant therapy during study
- Investigator judgment that continuing participation may harm the patient
- Pregnancy or breastfeeding during study
- Major violation of study procedures
- Withdrawal of consent
- Loss of contact after at least three attempts
- Development of conditions worsening prognosis during study
- Other administrative or investigator judgment reasons precluding completion of study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
State autonomous health care institution "Engels City Clinical Hospital No. 1"
Engel's, Russia, 413116
Actively Recruiting
2
Ivanovo Kuvaev Clinical Hospital
Ivanovo, Russia, 153025
Actively Recruiting
3
State Budgetary Institution of Healthcare of Moscow "City Polyclinic No. 2 of the Moscow Department of Healthcare"
Moscow, Russia, 117556
Actively Recruiting
4
Unimed-C Jsc
Moscow, Russia, 119571
Actively Recruiting
5
The State Budgetary Healthcare Institution of the Moscow Region "Moscow Regional Research Clinical Institute named after M.F. Vladimirsky"
Moscow, Russia
Actively Recruiting
6
Limited Liability Company "ErSi Medical"
Novosibirsk, Russia
Actively Recruiting
7
Professors' Clinic LLC.
Perm, Russia, 614070
Actively Recruiting
8
Limited Liability Company "Medical Center Eco-Safety"
Saint Petersburg, Russia, 19119
Actively Recruiting
9
Limited Liability Company "Energy of Health"
Saint Petersburg, Russia, 194156
Actively Recruiting
10
St. Petersburg State Budgetary Healthcare Institution "City Polyclinic No. 117"
Saint Petersburg, Russia, 194358
Actively Recruiting
11
Limited Liability Company "Clinic Zvezdnaya"
Saint Petersburg, Russia, 196158
Actively Recruiting
12
Limited Liability Company "Meili"
Saint Petersburg, Russia, 199406
Actively Recruiting
13
State Budgetary Institution "St. Petersburg Research Institute of Emergency Care named after I.I. Djanelidze"
Saint Petersburg, Russia
Actively Recruiting
14
Private institution of higher education "Medical University 'Reavis'"
Samara, Russia
Actively Recruiting
15
Association "Regional Medical Center 'Open Medicine'"
Tolyatti, Russia
Actively Recruiting
16
LLC "Polyclinic Polimedika Veliky Novgorod"
Veliky Novgorod, Russia
Actively Recruiting
17
Limited Liability Company "Medical Center for Diagnosis and Prevention Plus"
Yaroslavl, Russia
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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