Knee OsteoarthritisNCT04492670
Tui-na and Oral Chinese Medicine on KOA
A study testing Tui-na and Du-Huo-Ji-Sheng-Tang (DHJST) in people with Knee Osteoarthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on the treatment of KOA. This is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Tui-na and Du-Huo-Ji-Sheng-Tang (DHJST)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- 14 Sep 2020to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- of either gender (female must have either sterilization done or menopause)
- ≥50years of age
- meet the criteria of KOA according to the American College of Rheumatology
- Knee pain, and
- Any 4 of the following,
- ≥ 50 years of age
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- Less than 30 minutes of morning stiffness
- Crepitus on active motion
- Bony tenderness
- Bony enlargement
- No palpable warmth of synovium
- Osteophytes (Radiographic findings)
- with WOMAC score ≥ 39
- with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission)
Who cannot join
- Known knee pain caused by infection, malignant or autoimmune diseases
- Knee surgery or arthroscopy in the past year
- Chondroprotective or intra-articular injection in the past 4 months
- Systemic corticoid treatment in the past 4 months
- Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs
- Subject with uncontrolled hypertension
Show all 11Show fewer
- Local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks
- Known history of mental disorder
- Known history of serious acute organic disease
- Renal or liver function impairment
- Known allergy to or have drug interaction with the study herb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial
The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on the treatment of KOA.
This is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have 4-week of treatment, and then a 4-week follow-up.
Read the detailed description
The subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4, and week 8 for Chinese medicine practitioner (CMP) investigators assessments. The Western Ontario and McMaster University Osteoarthritis index (WOMAC) and EQ-5D-5L will be assessed and filled up at different timepoints. The treatment group will receive both Tui-na and study medication and the wait-list control group will receive Tui-na alone. CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit.
- Conditions
- Knee Osteoarthritis
- Being tested
- Tui-na, Du-Huo-Ji-Sheng-Tang (DHJST)
- Keywords
- Knee osteoarthritis, Tui-na, Chinese medicine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tui-naProcedure or surgery
For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience. The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.
Du-Huo-Ji-Sheng-Tang (DHJST)Drug
Also called Herbal granules
This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.
| Study group | Role | What they receive |
|---|---|---|
| Tui-na and oral Chinese medicine | Experimental | 8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks Receives: Procedure: Tui-na; Drug: Du-Huo-Ji-Sheng-Tang (DHJST) |
| Tui-na | Other | 8 sessions of 20 minutes Tui-na for 4 weeks Receives: Procedure: Tui-na |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
Measured: 4 weeks
Secondary outcomes (2)
EQ-5D-EL questionnaire
to assess health-related quality of life, one part is descriptive has 5 response level, the other part is VAS which ranges from 0 to 100
Measured: 8 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
Measured: at 2 weeks and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start14 Sep 2020
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Lin Zhixiu, Chinese University of Hong Kong
- Investigators
- Zhixiu Lin, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492670
- Sponsor's protocol ID
- KOA
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2020
- Last updated
- 27 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan KH, Ching JYL, Chan KL, Lau HY, Chu KM, Chan K, Pang HF, Wong LC, Chia CP, Zhang HW, Song T, Leung SB, Ng BFL, Lin ZX. Therapeutic effect of Duhuo Jisheng Decoction add-on Tui-na manipulation on osteoarthritis of knee: a randomized controlled trial. Chin Med. 2023 Jul 10;18(1):82. doi: 10.1186/s13020-023-00737-5.
PubMed 37424023
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Effect of a Combined Therapy of Tui-na and Oral Chinese Medicine on Osteoarthritis of Knee - A Randomized Wait-list Controlled Trial
- ClinicalTrials.gov ID
- NCT04492670
- Acronym / sponsor ID
- KOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Tui-na, Chinese medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on the treatment of KOA.
This is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have 4-week of treatment, and then a 4-week follow-up.
Detailed description
The subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4, and week 8 for Chinese medicine practitioner (CMP) investigators assessments. The Western Ontario and McMaster University Osteoarthritis index (WOMAC) and EQ-5D-5L will be assessed and filled up at different timepoints. The treatment group will receive both Tui-na and study medication and the wait-list control group will receive Tui-na alone. CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tui-na and oral Chinese medicine | Experimental | Procedure: Tui-na, Drug: Du-Huo-Ji-Sheng-Tang (DHJST)8 sessions of 20 minutes Tui-na for 4 weeks and take study medication (Herbal granules) twice daily concomitantly for 4weeks |
| Tui-na | Other | Procedure: Tui-na8 sessions of 20 minutes Tui-na for 4 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- of either gender (female must have either sterilization done or menopause)
- ≥50years of age
- meet the criteria of KOA according to the American College of Rheumatology
- with WOMAC score ≥ 39
- with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission)
Key exclusion criteria (11 listed)
- Known knee pain caused by infection, malignant or autoimmune diseases
- Knee surgery or arthroscopy in the past year
- Chondroprotective or intra-articular injection in the past 4 months
- Systemic corticoid treatment in the past 4 months
- Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tui-naFor administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience. The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures. | Procedure or surgery | Tui-na, Tui-na and oral Chinese medicine |
| Du-Huo-Ji-Sheng-Tang (DHJST)Also: Herbal granulesThis study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used. | Drug | Tui-na and oral Chinese medicine |
Primary outcome
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: 4 weeks
to assess the condition of patients with KOA, the minimum score is 0 and maximum is 96
2 secondary outcomes
EQ-5D-EL questionnaire
Time frame: 8 weeks
The Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: at 2 weeks and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Derived from this study: PubMed 37424023Chan KH, Ching JYL, Chan KL, Lau HY, Chu KM, Chan K, Pang HF, Wong LC, Chia CP, Zhang HW, Song T, Leung SB, Ng BFL, Lin ZX. Therapeutic effect of Duhuo Jisheng Decoction add-on Tui-na manipulation on osteoarthritis of knee: a randomized controlled trial. Chin Med. 2023 Jul 10;18(1):82. doi: 10.1186/s13020-023-00737-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhixiu Lin, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tui-na and Du-Huo-Ji-Sheng-Tang (DHJST) in people with Knee Osteoarthritis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.