NCT04029649

Brief Summary

The aim of this study is to determine the efficacy and safety of Beta-1,3/1,6-D-Glucan from mycelium extract of Ganoderma lucidum on ulcerative colitis

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
204

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 2, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

July 17, 2019

Last Update Submit

July 31, 2019

Conditions

Ulcerative Colitis

Keywords

Beta-1,3/1,6-D-GlucanGanoderma lucidumUlcerative colitis

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life: SF-36 questionnaire

    Quality of Life is assessed by Indonesian validated Short Form 36 (SF-36) questionnaire. This questionnaire consist of 36 items/questions that evaluate quality of life in some elements. The elements are change in health (1 item), general health perception (5 items), energy/fatigue (4 items), mental health (5 items), social functioning (2 items), pain (2 items), physical functioning (10 items), role limitations due to emotional problems (3 items) and role limitations due to physical problems (4 items). The score from each question will be summed. Minimum score is 36 and maximum score is 138. Higher score indicates higher quality of life and lower score indicates lower quality of life. Higher score post intervention administration represents a positive outcome

    0 and 90 days

Secondary Outcomes (7)

  • Change of C-Reactive Protein (CRP) level

    0 and 90 days

  • Change of Erythrocyte Sedimentation Rate (ESR)

    0 and 90 days

  • Change of Tumor Necrosis Factor Alpha (TNF-α) level

    0 and 90 days

  • Change of Interleukin 6 (IL-6) level

    0 and 90 days

  • Change of fecal calprotectin level

    0 and 90 days

  • +2 more secondary outcomes

Other Outcomes (2)

  • Number of participants with adverse events (AEs)

    30, 60 and 90 days

  • Number of participants with serious adverse events (SAEs)

    30, 60 and 90 days

Study Arms (2)

Beta-1,3/1,6-D-Glucan Ganoderma lucidum

EXPERIMENTAL

This group received capsule contains 180 mg Beta-1,3/1,6-D-Glucan from mycelium extract of Ganoderma lucidum with dose 3x1 capsule a day for 90 days

Drug: Beta-1,3/1,6-D-Glucan

Placebo

PLACEBO COMPARATOR

This group received empty capsule with dose 3x1 capsule a day for 90 days

Drug: Placebo

Interventions

Beta-1,3/1,6-D-GlucanDRUG

Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days

Beta-1,3/1,6-D-Glucan Ganoderma lucidum
PlaceboDRUG

Placebo capsule three times daily for 90 days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥18 years old
  • ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg
  • agreed to participate in this study

You may not qualify if:

  • ulcerative colitis patients who are treated by corticosteroid, immunosuppressive agents and biologic agents
  • allergic to Ganoderma lucidum
  • could not be randomised and participate in this study by clinical judgement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)

Jakarta, Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Marcellus Simadibrata

    Division Of Gastroenterology Department Of Internal Medicine Faculty Of Medicine Universitas Indonesia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcellus Simadibrata

CONTACT

0816920448marcellussimadibrata57@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 17, 2019

First Posted

July 23, 2019

Study Start

August 1, 2019

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 2, 2019

Record last verified: 2019-07

Locations

ID(1)