The Efficacy of TGF for Treating Osteoarthritis of the Knee

NCT03562429 | Unknown Phase 2

• 1 other identifier: CMUH107-REC2-044
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is to evaluate the efficacy of herbal formula TGF treating knee joint osteoarthritis(KOA) and its biochemical mechanism. The study design is a parallel randomized, placebo-controlled, double-blind clinical trial includes 180 patients with KOA. The patients are random allocated into study group(taking TGF) and control group(taking 1/20 TGF). After the 12 weeks treatment course, another 4 weeks is to follow-up the condition without medication. Assessments will be performed before and after treatment and the end of follow-up period. The inclusion criteria are (1) age between 50\~75 years old, (2) diagnosis of osteoarthritis: The Clinical/Radiographic classification criteria of American College of Rheumatology, American College of Rheumatology, (3) chronic knee pain over 3 months. The exclusion criteria are (1) the past history with systemic joint disease, such as autoimmune disease, (2) the patient with history of knee surgery or waiting for the total knee replacement, (3) any disease that affect the function of lower extremities, such as trauma, tumor or compensation of abnormal posture, (4) the condition that cannot participate this study, (5) the subjects non-compliance with the protocol. The Assessments including primarily the WOMAC (VAS version, 3.1), VAS and the used dosage of Celebrex before and after treatment. The secondary assessments are (1) X ray, (2) Constitution in Chinese Medicine Questionnaire, (3) Short From-36, (4) erythrocyte sedimentation rate and C reactive protein, (5) Biomarkers: C-telopeptide of type II collagen, cartilage oligomeric matrix protein, Osteocalcin, Leptin, Interleukin-1, Interleukin-6, matrix metalloproteinase-3, matrix metalloproteinase-13, ADAMTS-4, transglutaminase-2, and (6) metabolomics.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (6)

• Western Ontario & McMaster Universities Osteoarthritis Index

  This scale is the VAS version, 3.1 and divided into three sub-scales -- pain, stiffness and function. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing. Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item has 0-100 mm to evaluate the status and the higher values represent a worse outcome. These three sub-scales were summed to a total score (0-2400 mm).

  Change from Baseline WOMAC VAS version 3.1 at 3 months

• Visual Analogue Scale for pain

  To evaluate the status of knee pain when check point. Using 0-100 mm scale is to evaluate knee pain by visual analogue scale. "0" is no pain and "100" is the worst pain that subjects had experienced before. The subject gives the value under the moment of check point.

  Change from Baseline Visual Analogue Scale for pain at 3 months

• the used dosage of Celebrex

  To evaluate the dosage of Celebrex when check point

  Change from Baseline the used dosage of Celebrex at 3 months

• Western Ontario & McMaster Universities Osteoarthritis Index

  This scale is the VAS version, 3.1 and divided into three sub-scales -- pain, stiffness and function. Pain (5 items): during walking, using stairs, in bed, sitting or lying, and standing. Stiffness (2 items): after first waking and later in the day. Physical Function (17 items): stair use, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on / taking off socks, rising from bed, lying in bed, getting in / out of bath, sitting, getting on / off toilet, heavy household duties, light household duties. Each item has 0-100 mm to evaluate the status and the higher values represent a worse outcome. These three sub-scales were summed to a total score (0-2400 mm).

  Change from Baseline WOMAC VAS version 3.1 at 4 months

• Visual Analogue Scale for pain

  To evaluate the status of knee pain when check point. Using 0-100 mm scale is to evaluate knee pain by visual analogue scale. "0" is no pain and "100" is the worst pain that subjects had experienced before. The subject gives the value under the moment of check point.

  Change from Baseline Visual Analogue Scale for pain at 4 months

• the used dosage of Celebrex

  To evaluate the dosage of Celebrex when check point

  Change from Baseline the used dosage of Celebrex at 4 months

Secondary Outcomes (48)

• X ray

  Change from Baseline X ray at 3 months

• X ray

  Change from Baseline X ray at 4 months

• Constitution in Chinese Medicine Questionnaire, CCMQ

  Change from Baseline CCMQ at 3 months

• Constitution in Chinese Medicine Questionnaire, CCMQ

  Change from Baseline CCMQ at 4 months

• WHOQOL-BREF

  Change from Baseline WHOQOL at 3 months

Study Arms (2)

TGF group (study group)

EXPERIMENTAL

Use TGF to treat osteoarthritis of the knee, 5g/time, 3 times a day, for 12 weeks.

Drug: TGF

TGFP group (placebo group)

PLACEBO COMPARATOR

Use TGFP to treat osteoarthritis of the knee, 5g/time, 3 times a day, for 12 weeks.

Drug: TGFP

Interventions

TGF DRUG

TGF is a powder formulation of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..

Also known as: Hu-Qian Wan

TGF group (study group)

TGFP DRUG

TGFP is 1/20 concentration of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..

Also known as: the placebo of Hu-Qian Wan

TGFP group (placebo group)

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 50\~75 years old
• diagnosis of osteoarthritis: The Clinical/Radiographic classification criteria of American College of Rheumatology, ACR
• chronic knee pain over 3 months.

You may not qualify if:

• the past history with systemic joint disease, such as autoimmune disease
• the patient with history of knee surgery or waiting for the total knee replacement
• any disease that affect the function of lower extremities, such as trauma, tumor or compensation of abnormal posture
• the condition that cannot participate this study
• the subjects non-compliance with the protocol

Sponsors & Collaborators

• China Medical University Hospital: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Hen-Hong Chang

  Dean of Chinese medicine, China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hen-Hong Chang

CONTACT

886-4-22053366; tcmchh55@gmail.com

Study Design

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

Model Details: 180 subjects are divided into treatment group and control group (placebo).

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 19, 2018
• Study Start: August 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 21, 2018

Record last verified: 2018-06