Evaluation of the effect of edible traditional product” Dawa-e-balgham” on the pain of knee osteoarthritis

Phase 3

Recruiting

Conditions: Condition 1: Knee osteoarthritis. Condition 2: Functional dyspepsia.
Osteoarthritis of knee
Functional dyspepsia

Registration Number: IRCT20190807044470N1

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Knee pain at least one for most days of the prior month, in addition to at least 5 of the following 6:
Crepitus on active joint motion
Morning stiffness less than 30 minutes’ duration
Bony enlargement of the knee on examination
Bony tenderness of the knee on examination
No palpable warmth.
Age older than 50 years
Average pain on the Visual Analogue Scale ( VAS ) =30 out of 100 mm.

Exclusion Criteria

History of knee surgery
Knee pain related to rheumatological disease or other conditions such as infectious diseases
Pregnancy and breast feeding
Presence of inflammatory rheumatic diseases
Being treated with any of the complementary medicine the prior 3 month
Self management of pain by sedatives and anti inflammatory drugs
Using of corticostereoid less than last 5 weeks ago
Intra-articular depo corticostereoid injection in less than 3 last months.
Intra articular hyaloronate injection in less than past 6 months
Arthroscopy in past one years
history of Significant knee trauma in less than past 6 months
Contraindication for paracetamol using
history of severe cardiac,renal and liver disease
Anticoagulant drugs using
Worrying in heat and dryness

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain severity score on the visual analogue scale. Timepoint: At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic capsules. Method of measurement: Visual analogue Scale.

Secondary Outcome Measures

Name	Time	Method
Functional dyspepsia severity score. Timepoint: At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic capsules. Method of measurement: the Leeds Dyspepsia Questionnaire (LDQ).;Quality of life score. Timepoint: At baseline (before baseline) and 14 days later (at the end of Wash out period) and at week 4, 8, 12, 16 after administration of prophylactic. Method of measurement: Knee injury and Osteoarthritis Outcome Score (KOOS).;Diagnose of functional dyspepsia score. Timepoint: At baseline (before baseline). Method of measurement: Rome III questionnaire.