Beta-1,3/1,6-D-Glucan Ganoderma Lucidum on Ulcerative Colitis

Ulcerative Colitis Clinical Trial

Official title:

The Role of Beta-1,3/1,6-D-Glucan From Mycelium Extract of Indonesian Ganoderma Lucidum on Ulcerative Colitis: A Double-Blind Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04029649
• Other study ID #: 19-01-0083
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 2019
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Fakultas Kedokteran Universitas Indonesia
• Contact: Marcellus Simadibrata
• Phone: 0816920448
• Email: marcellussimadibrata57[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 204
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years old

• ulcerative colitis patients who are treated by 5-aminosalicylic acid (5-ASA) 3x500 mg

• agreed to participate in this study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
Indonesia	RSUPN dr. Cipto Mangunkusumo (Cipto Mangunkusumo Hospital)	Jakarta	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Fakultas Kedokteran Universitas Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events (AEs)	Number of participants with AE in this study	30, 60 and 90 days
Other	Number of participants with serious adverse events (SAEs)	Number of participants with SAEs in this study	30, 60 and 90 days
Primary	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	Change of C-Reactive Protein (CRP) level	Level of CRP is obtained from laboratory test.	0 and 90 days
Secondary	Change of Erythrocyte Sedimentation Rate (ESR)	ESR is obtained from laboratory test.	0 and 90 days
Secondary	Change of Tumor Necrosis Factor Alpha (TNF-a) level	Level of TNF-a is obtained from laboratory test	0 and 90 days
Secondary	Change of Interleukin 6 (IL-6) level	Level of IL-6 is obtained from laboratory test	0 and 90 days
Secondary	Change of fecal calprotectin level	Level of fecal calprotectin is obtained from stool examination	0 and 90 days
Secondary	Change of Mayo score	Mayo score is assessed from colonoscopy. 0 = normal 1 = mild (erythema, decreased vascular pattern, mild friability) 2 = moderate (marked erythema, absent vascular pattern, friability, erosions) 3 = severe (spontaneous bleeding, ulceration)	0 and 90 days
Secondary	Number of patients with neutrophils infiltrating crypt epithelium in colon biopsy	Colon biopsy is obtained from colonoscopy and histopathology examination	0 and 90 days