Influence of drug containing ginger extract on arthritic pain and gastropathy in patients with osteoarthritis
| ISRCTN | ISRCTN48110500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48110500 |
| Secondary identifying numbers | 616-08:612.018;612.4:616.7 |
- Submission date
- 07/08/2010
- Registration date
- 26/11/2010
- Last edited
- 26/11/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Vladimir Drozdov
Scientific
Scientific
Central Scientific Research Institute of Gastroenterology
Shosse Entuziastov,86
Moscow
111123
Russian Federation
| Phone | +7 (8)495 304 1942 |
|---|---|
| zvopt@yandex.ru |
Study information
| Study design | Randomised active controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet (Russian only) |
| Scientific title | Influence of drug containing ginger extract on arthritic pain and gastropathy in patients with osteoarthritis: a randomised active controlled clinical trial |
| Study objectives | Traditional non-steroidal anti-inflammatory drugs (NSAIDs) inhibit COX-1,2 expression leading to the lack of prostaglandins (PG). PG play a crucial role in mechanisms of mucosal defense. This drug containing ginger extract inhibits COX-2 and increases PG production in gastric mucosa. It seems to be an alternative to traditional NSAIDs especially in patients with osteoarthritis with risk factors of NSAID-induced gastropathy. |
| Ethics approval(s) | Local Ethics Committee of Central Scientific Research Institute of Gastroenterology approved on the 31st August 2007 |
| Health condition(s) or problem(s) studied | Osteoarthritis, NSAID-induced gastropathy |
| Intervention | The patients were randomised in two groups, using methods of envelopes, to: 1. Group ZG (n = 21): ginger and glucosamine combination (Zinaxin Glucosamine: 170 mg ginger extract [Zingiber officinalis, EV.EXT 35] and 500 mg glucosamine, as glucosamine sulphate, per capsule, Ferrosan AS, Denmark) 2 capsules orally daily 2. Group DG (n = 22): diclofenac and glucosamine combination (100 mg diclofenac as sodium diclofenac and 1000 mg glucosamine as glucosamine sulphate) daily The duration of treatment was 28 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ginger extract, diclofenac |
| Primary outcome measure | Upper GI lesions (erosion, ulcer) were assessed on the 28 day of treatment with upper GI endoscopy |
| Secondary outcome measures | Gastritis |
| Overall study start date | 01/06/2008 |
| Completion date | 01/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Aged over 18 years, either sex 2. Osteoarthritis (OA) pain syndrome availability of more than 40 mm according to Visual Analogue Scale (VAS) 3. Requiring anti-inflammatory therapy assignment 4. NSAID-gastropathy or dyspepsia development from NSAID therapy in anamnesis 5. Informed patient consent to administer the preparation 6. Compliance with the listed research protocol |
| Key exclusion criteria | 1. Ulcer presence during upper gastrointestinal (GI) endoscopy and more than 5 stomach mucosa and/or duodenum erosions, and/or erosive oesophagitis 2. High risk of cardiological complications, arterial hypertension, cardiac insufficiency greater than II degree, myocardial infarction or apoplectic attack in anamnesis during the previous 3 years, chronic kidney disease, liver insufficiency, bronchial asthma, subcompensated or decompensated diabetes mellitus, oncological diseases 3. NSAID administration, aspirin in anti-aggregant doses, glucocorticosteroids 4. Pregnancy |
| Date of first enrolment | 01/06/2008 |
| Date of final enrolment | 01/06/2009 |
Locations
Countries of recruitment
- Russian Federation
Study participating centre
Central Scientific Research Institute of Gastroenterology
Moscow
111123
Russian Federation
111123
Russian Federation
Sponsor information
Central Scientific Research Institute of Gastroenterology (Russia)
Research organisation
Research organisation
c/o Vladimir N. Drozdov
Shosse Entuziastov, 86
Moscow
111123
Russian Federation
| Phone | +7 (8)495 304 1942 |
|---|---|
| zvopt@yandex.ru |
Funders
Funder type
Research organisation
Central Scientific Research Institute of Gastroenterology (Russia) - Healthcare Department
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
