NCT02875691

Brief Summary

This randomized double blind clinical trial performed on 68 patients (32 in intervention and 36 in control group) diagnosed with SLE. The patients in intervention group were given daily dose of 1000mg of aqueous green tea extract (of 6 gram of dried green tea leaf) in form of two capsules ( 500 mg). Also in control group, the patients were given daily dose of 1000mg of cellulose in form of two capsules ( 500 mg) Variables include SLE disease activity, some biomarkers of inflammation and oxidative stress and anthropometric indicators at baseline and end of the study. The investigators used SLEDAI (systemic lupus erythematous disease activity index ) questionnaire for evaluating the clinical signs of the disease. The questionnaires filled out at baseline and after 3 month.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 23, 2016

Completed
Last Updated

August 23, 2016

Status Verified

May 1, 2016

Enrollment Period

6 months

First QC Date

May 28, 2016

Last Update Submit

August 18, 2016

Conditions

AutoimmuneLupus Erythematosus, Systemic

Keywords

disease activity

Outcome Measures

Primary Outcomes (1)

  • systemic lupus erythematous Disease Activity

    Clinical signs consist of 24 items, 16 of which are clinical items such as seizure, psychosis, organic brain syndrome, visual disturbance, other neurological problems, hair loss, new rash, muscle weakness, arthritis, blood vessel inflammation, mouth sores, chest pain worse with deep breathing and manifestations of pleurisy and/or pericarditis and fever consistency.Eight of the 24 items are laboratory results such as urinalysis testing, blood complement levels, increase anti-DNA antibody levels, low platelets, and low white blood cell count. these items assessed by SLEDAI questionnaire

    Three months after starting of intervention

Secondary Outcomes (2)

  • measurement of some proinflammatory and anthropometric markers

    At baseline and after three months of intervention

  • Health-Related Quality of Life

    At baseline and after three months of intervention

Other Outcomes (3)

  • Dietary intake

    at baseline and after 3 month of intervention

  • Weight

    at baseline and after 3 month of intervention

  • BMI

    at baseline and after 3 month of intervention

Study Arms (2)

green tea extract

ACTIVE COMPARATOR

Patients were given daily dose of 1000mg aqueous green tea extract (of 6 grams of dried green tea leaf) in the form of 2 capsules (500 mg) for three months.

Dietary Supplement: green tea extract

Placebo

PLACEBO COMPARATOR

Patients in placebo group received daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months

Dietary Supplement: placebo

Interventions

green tea extractDIETARY_SUPPLEMENT

Patients are given daily dose of 1000mg aqueous green tea extract (of 6 grams of dried green tea leaf) in the form of 2 capsules( 500 mg) for three months.

green tea extract
placeboDIETARY_SUPPLEMENT

Patients in placebo group receive daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months

Placebo

Eligibility Criteria

Age15 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patients older than 15 years,diagnosed with systemic lupus erythematous (SLE) according to ACR(American College of Rheumatology) criteria.

You may not qualify if:

  • Patients with other autoimmune diseases (diabetes, ...)
  • Cardiovascular disease
  • Patients with infectious or liver disease;
  • severe infection
  • Pregnancy
  • Breastfeeding
  • Smoking
  • Alcohol consumption
  • Use of any dietary supplements
  • Changing of medication during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iran

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Tea

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Iran Ahvaz

    Ahvaz University of Medical Sceinces, Ahvaz, Iran

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
zahra shamekhi , phd student in Ahvaz Jundishapur University of Medical Sciences

Study Record Dates

First Submitted

May 28, 2016

First Posted

August 23, 2016

Study Start

September 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 23, 2016

Record last verified: 2016-05

Locations

IR(1)