Trial no.:	PACTR201705002287258	Date of Registration:	11/05/2017
Trial Status:	Retrospective registration - This trial was registered after enrolment of the first participant

TRIAL DESCRIPTION

Public title

Cucumis sativus extract

Official scientific title

Effectiveness of a Cucumis sativus extract versus Glucosamine-Chondroitin used as placebo in the management of osteoarthritis: a randomized controlled trials

Brief summary describing the background and objectives of the trial

To evaluate the ability of Cucumis sativus extract to improve knee symptoms in OA compared to placebo (combination of glucosamine hydrochloride and chondroitin sulphate (GC)).

Type of trial

RCT

Acronym (If the trial has an acronym then please provide)

IPG

Disease(s) or condition(s) being studied

Musculoskeletal Diseases,osteoarthritis

Sub-Disease(s) or condition(s) being studied

Purpose of the trial

Cucumis sativus extract

Anticipated trial start date

01/03/2016

Actual trial start date

01/03/2016

Anticipated date of last follow up

01/09/2016

Actual Last follow-up date

01/09/2016

Anticipated target sample size (number of participants)

150

Actual target sample size (number of participants)

122

Recruitment status

Completed

Publication URL

Secondary Ids	Issuing authority/Trial register

STUDY DESIGN
Intervention assignment	Allocation to intervention	If randomised, describe how the allocation sequence was generated	Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms	Masking	If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously	Randomised	randomization table was generated using the validated computer software CODE (IDV, Gauting, Germany).	Allocation was determined by the holder of the sequence who is situated off site	Masking/blinding used	Care giver/Provider

INTERVENTIONS
Intervention type	Intervention name	Dose	Duration	Intervention description	Group size	Nature of control
Experimental Group	IPG group	10mg, twice daily	180 days	Patients with symptoms of mild to moderate OA. Endpoints included the change from baseline through Day 180 versus the placebo (GC group) for all endpoints, including the following scores: (1) mean VAS; (2) mean WOMAC subscales; (3) LFI; and (4) knee flexion.	61	Active-Treatment of Control Group
Control Group	Glucosamine+Chondrointin (GC)	10mg twice daily	180 days	Patients with symptoms of mild to moderate OA. Endpoints included the change from baseline through Day 180 versus the placebo (GC group) for all endpoints, including the following scores: (1) mean VAS; (2) mean WOMAC subscales; (3) LFI; and (4) knee flexion.	61	Placebo

ELIGIBILITY CRITERIA
List inclusion criteria	List exclusion criteria	Age Category	Minimum age	Maximum age	Gender
¿ Ambulatory, 40¿75 years of age, with a BMI of 18 to 30 kg/m2 ¿ Females of childbearing age must agree to use a medically approved form of birth control and have a negative urine pregnancy test result throughout the study ¿ Female subjects of limited to no childbearing potential must be amenorrheic for at least 1 year or have had a hysterectomy, a bilateral oophorectomy, or both ¿ Unilateral or bilateral OA of the knee for greater than 3 months plus a Kellgren and Lawrence radiographic grade of 2 or 3 ¿ VAS score during knee movement between 40¿70 mm after 7 day withdrawal of excluded medications ¿ LFI score between 6¿10 points after 7 day withdrawal of excluded medications ¿ Clinical laboratory results that are within normal range or considered not clinically significant by the Principal Investigator ¿ Be willing to participate in all scheduled visits, tests, and other trial procedures according to the clinical protocol ¿ Be willing to refrain from taking ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription) during the entire trial other than acetaminophen (paracetamol) as rescue medication ¿ Provide a signed and dated informed consent indicating that the subject has been informed of all pertinent aspects and possible risks associated with participation in the trial	¿ History of hypersensitivity to the rescue medication or any of the products used in the study ¿ History of hypersensitivity to eggs, chicken or fowl, or shellfish ¿ History of inflammatory arthropathy, severe RA, OA (VAS score greater than 70), or Systemic Lupus Erythematosus ¿ Hyperuricemia (>440 ¿mol/L), past history of gout, or both ¿ Anticipation of surgery within the next 4 months ¿ Recent injury in the target knee (past 4 months) ¿ History of use for corticosteroid, indomethacin, glucosamine & chondroitin within 3 months of Visit 2; intra-articular treatments, including injections of corticosteroid or hyaluronic acid; consumption of Omega 3 fatty acids dietary supplements within 6 months preceding the treatment period (a 2-week washout period is allowed for subjects taking omega 3 fatty acid supplements) ¿ History of congestive heart failure ¿ Anticipated problems with product consumption ¿ Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies within the last 5 years ¿ High alcohol intake (>2 standard drinks per day) or use of recreational drugs (e.g., cocaine, methamphetamine, marijuana, etc.) ¿ Females who are pregnant or lactating or planning to become pregnant ¿ History of any mental illness that might impair the ability of subjects to provide a written informed consent ¿ Consumed acetaminophen (paracetamol), ibuprofen, aspirin or other NSAIDS, or any other pain reliever (OTC or prescription), or any natural health product, (excluding vitamins) within 7 days of first visit ¿ Participation in any clinical trials within 30 days prior to first visit		40 Year(s)	75 Year(s)	Both

ETHICS APPROVAL

Has the study received appropriate ethics committee approval

Date the study will be submitted for approval

Date of approval

Name of the ethics committee

Yes

11/01/2016

CNERSH

Ethics Committee Address
Street address	City	Postal code	Country
Messa	Yaounde		Cameroon

OUTCOMES
Type of outcome	Outcome	Timepoint(s) at which outcome measured
Primary Outcome	The primary endpoint was defined as the change in total WOMAC score from the baseline through Day 180 for the IPG® group versus the placebo (GC group).	follow-up evaluation on Day 30 Day 60 Day 90 Day 120 Day 180.
Primary Outcome	Change from baseline through day 180 versus GC for all endpoints including the following scores: (1) mean VAS; (3) LFI; and (4) knee flexion	follow-up evaluation on Day 30 Day 60 Day 90 Day 120 Day 180
Secondary Outcome	secondary endpoints included the change in serum biomarker, C-reactive protein (CRP) plus synovial fluid biomarkers interleukin (IL)-6, and matrix metalloproteinase (MMP)-3	follow-up evaluation on Day 30 Day 60 Day 90 Day 120 Day 180

RECRUITMENT CENTRES
Name of recruitment centre	Street address	City	Postal code	Country
Laboratory of Nutrition and Nutritional Biochemistry	Lycee Leclerc	Yaounde	812	Cameroon

FUNDING SOURCES
Name of source	Street address	City	Postal code	Country
Immino Tech Inc.	Nye Lane	Carson city	NV 89706	United States of America

SPONSORS
Sponsor level	Name	Street address	City	Postal code	Country	Nature of sponsor
Secondary Sponsor	gateway Health Alliance	California	NY		United States of America	Commercial Sector/Industry
Secondary Sponsor	Laboratory of Nutrition and Nutritional Biochemistry	lycee Leclerc	Yaounde		Cameroon	University

COLLABORATORS
Name	Street address	City	Postal code	Country
Robert Nash	PhytoQuest Limited	Aberystwyth, Ceredigion	SY23 3EB	United Kingdom
Hazel Sharp	PhytoQuest Limited	Aberystwyth, Ceredigion	SY23 3EB	United Kingdom
Velmurugan Shanmugham	Samrat Layout	Karnataka	Bangalore 560076	India

CONTACT PEOPLE
Role	Name	Email	Phone	Street address
Principal Investigator	Robert NASH	robert.nash@phytoquest.co.uk	+44 1970 823 200	Plas Gogerddan, Aberystwyth, Ceredigion SY23 3EB, UK
City	Postal code	Country	Position/Affiliation
		United Kingdom	PhytoQuest Limited
Role	Name	Email	Phone	Street address
Public Enquiries	Harinder Singh	harinder.singh@treataid.com	+911244056004	unit 417 Sector 2
City	Postal code	Country	Position/Affiliation
		India	Harinder Medicare
Role	Name	Email	Phone	Street address
Scientific Enquiries	Velmurugan Shanmugham	vp@biogenero.in	+44.1970823200	Bannerghatta Road, 560076
City	Postal code	Country	Position/Affiliation
Bangalore	560076	India	biogenero

REPORTING
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URL	Results Available	Results Summary	Result Posting Date	First Journal Publication Date

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Result URL Hyperlinks	Link To Protocol
Result URL Hyperlinks

Changes to trial information

Pan African Clinical Trials Registry