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2 x 10 mg Natura-alpha capsules for Colitis

Phase 2
Waitlist Available
Research Sponsored by Natrogen Therapeutics International, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 28
Awards & highlights
All Individual Drugs Already Approved

Summary

This study is to evaluate the efficacy and tolerability of multiple oral doses of Natura-alpha capsule administered to patients with active ulcerative colitis. This will be a randomized, double-blind, placebo-controlled, parallel-design study. Up to 75 patients will complete this study (20 to 25 patients per treatment group) at approximately 10-12 clinical sites in the Unites States. Patients will be assigned at a 1:1:1 ratio to receive placebo, Natura-alpha 10 mg or Natura-alpha 20 mg, b.i.d. Replacement patients may be added, pending Sponsor approval, if it appears that less than 60 patients will complete the study.

Eligible Conditions
  • Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Physician's Global Assessment(PGA)
Secondary study objectives
Physician's Global Assessment (PGA)
Safety

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: 2 x 10 mg Natura-alpha capsulesExperimental Treatment1 Intervention
2 x 10mg Natura-alpha capsules administered orally with water, b.i.d.
Group II: 10mg Natura-alpha + 10 mg placeboExperimental Treatment1 Intervention
10 mg Natura-alpha capsule + 10 mg placebo capsule administered orally with water, b.i.d.
Group III: 2 x 10 mg placebo capsulePlacebo Group1 Intervention
2 x 10 mg placebo capsules, administered orally with water, b.i.d.

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Who is running the clinical trial?

Natrogen Therapeutics International, IncLead Sponsor
Longgui Wang, MDStudy DirectorNatrogen Therapeutics International, Inc
~5 spots leftby Nov 2025
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