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

Evaluation of the effect of edible traditional product” Dawa-e-balgham” on the pain of knee osteoarthritis patients with functional dyspepsia compared to the control group: randomized double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190807044470N1
Enrollment
100
Registered
2019-11-27
Start date
2019-12-06
Completion date
Unknown
Last updated
2019-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Intervention group 1: patients who receive oral capsule ( 500 mg) of Dawa-Balgham containing Nigella sativa L.,Trachyspermum ammi, zataria multiflora and mastic (gum) after each meal

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFariba Hadi

Tehran University of Medical Sciences

hadiyari1000@gmail.com009888974535

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026