Contact information
Type
Scientific
Primary contact
Prof Vladimir Drozdov
ORCID ID
Contact details
Central Scientific Research Institute of Gastroenterology
Shosse Entuziastov,86
Moscow
111123
Russian Federation
+7 (8)495 304 1942
zvopt@yandex.ru
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
616-08:612.018;612.4:616.7
Study information
Scientific title
Influence of drug containing ginger extract on arthritic pain and gastropathy in patients with osteoarthritis: a randomised active controlled clinical trial
Acronym
Study hypothesis
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
Local Ethics Committee of Central Scientific Research Institute of Gastroenterology approved on the 31st August 2007
Study design
Randomised active controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (Russian only)
Condition
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
Phase
Phase IV
Drug names
Ginger extract, diclofenac
Primary outcome measures
Upper GI lesions (erosion, ulcer) were assessed on the 28 day of treatment with upper GI endoscopy
Secondary outcome measures
Gastritis
Overall trial start date
01/06/2008
Overall trial end date
01/06/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant 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
Recruitment start date
01/06/2008
Recruitment end date
01/06/2009
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Central Scientific Research Institute of Gastroenterology
Moscow
111123
Russian Federation
Sponsor information
Organisation
Central Scientific Research Institute of Gastroenterology (Russia)
Sponsor details
c/o Vladimir N. Drozdov
Shosse Entuziastov
86
Moscow
111123
Russian Federation
+7 (8)495 304 1942
zvopt@yandex.ru
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Central Scientific Research Institute of Gastroenterology (Russia) - Healthcare Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary