Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT04977557
Eligibility Criteria:
Inclusion Criteria:
1. Any person admitted to CMCH as a Suspected thiamine deficiency related peripheral Neuropathy / Possible dry-beriberi:
Risk factors + at least 2 of the following signs:
Risk factors include Imbalanced diet (diet poor in thiamine/rich in carbohydrate or anti-thiamine factors), malnutrition, alcoholism, Gastrointestinal surgery, chronic diarrhoea, chronic vomiting, pregnancy or history of recent delivery, chronic. diuretics use, renal dialysis, total parenteral nutrition.
1. Muscle weakness of upper and or lower limb (less than grade 5 power in MRC scale)
2. Positive sensory symptoms (burning, tingling or pain)
3. Objective sensory deficit (pain, touch, position, vibration sense )
4. Absent or reduced deep tendon reflexes
5. Positive squat test (unable to rise after squatting without help)
6. Leg swelling
2. Age 18 years and above.
Exclusion Criteria:
1. Patients with isolated cardiac/wet beriberi.
2. Patient with known causes of peripheral neuropathy such as Diabetic, hereditary, Demyelinating (GBS, CIDP), metabolic (hepatic/renal impairment), drugs (e.g. Isoniazid, Ethambutol, Phenytoin, Metronidazole, Dapsone etc.) Toxin (As ,Organo-phosphate Compound (OPC), Pb ,Hg except alcohol) etc.
3. Patients refuse to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04977557
Study Brief:
Protocol Section:
NCT04977557