The efficacy of Chinese herbal recipe versus diclofenac in symptomatic treatment of osteoarthritis of the knee
| ISRCTN | ISRCTN70292892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70292892 |
| Protocol serial number | 67/2002 |
| Sponsor | Chiang Mai University - Faculty of Medicine (Thailand) |
| Funder | Chiang Mai University (Thailand) - Endowment Fund for Medical Research, Faculty of Medicine |
- Submission date
- 29/11/2004
- Registration date
- 29/11/2004
- Last edited
- 07/08/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Supanimit Teekachunhatean
Scientific
Scientific
Department of Pharmacology
Faculty of Medicine
Chiang Mai University
Chiang Mai
50200
Thailand
| steekach@mail.med.cmu.ac.th |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Osteoarthritis (OA) of the knee |
| Intervention | 1st Group: Chinese herbal medicine (6 capsules after meal, 3 times a day) plus placebo of diclofenac (1 capsule after meal, 3 times a day) 2nd Group: Placebo of Chinese herbal medicine (6 capsules after meal, 3 times a day) plus diclofenac (1 capsule after meal, 3 times a day) |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chinese herbal recipe versus diclofenac |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 200 |
| Key inclusion criteria | Patients who had been suffering from unilateral or bilateral OA of the knee according to the criteria of the American College of Rheumatology for more than 3 months |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/01/2004 |
Locations
Countries of recruitment
- Thailand
Study participating centre
Department of Pharmacology
Chiang Mai
50200
Thailand
50200
Thailand
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 13/12/2004 | Yes | No |