Condition category
Musculoskeletal Diseases
Date applied
07/08/2010
Date assigned
26/11/2010
Last edited
26/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes