A clinical trial to compare the effects of Unani research drug Qurs-e-Mafasil with allopathic drug Paracetamol in patients with Osteoarthritis

Phase 2

Not yet recruiting

• Conditions: Osteoarthritis of knee, unspecified,

• Registration Number: CTRI/2021/12/038829
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a single blindrandomized parallel group trial in patients with Tahajjural-Mafasil(Osteoarthritis).  Patients will be enrolled if theysatisfy inclusion and exclusion criteria. The patients enrolled in thestudy will receive the medicine Qurs-e- Mafasil or Tablet Paracetamol  as allocated by randomization method. Thetotal duration of treatment will be 8 weeks and the follow-up for all clinicalparameters will be conducted every two weeks. The laboratory tests will beconducted at all follow ups.

Composition ofQurs-e- Mafasil 

| | | | |

| --- | --- | --- | --- |

|S. No.

Ingredients

Scientific names

Quantity

|1.

Zanjabeel

*Zingiber officinale R.*

1 part

|2.

Suranjan

*Colchicum luteum B.*

2 parts

|3.

FilfilSiyah

*Piper nigrum L.*

1 part

|4.

Asgand

*Withaniasomnifera D.*

1 part

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-12-21
• Study Start: 2021-12-31

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Subjects fulfilling ACR clinical criteria for knee OA; andor 2.
• Subjects having grade II and III Osteoarthritisin knee radiography as perKellegrenLawrence criteria 3.
• Subjects presenting with/ without the following signs and symptoms: Joint Pain Early morning stiffness Tenderness Swelling Reduced mobility.

Exclusion Criteria

• Subjects having Rheumatoid arthritis, Systemic joint disease or any other type of arthritis 2.
• Obese Subjects having BMI>30 3.
• Subjects with uncontrolled Hypertension, Diabetes Mellitus, Tuberculosis, Malignancy, Epilepsy and any other disease requiring long-term treatment 4.
• Known cases of Renal/ hepatic impairment 5.
• Patient receiving Intra-articular treatment (e.g., Corticosteroid or Hyaluronic acid) or treatment with medicine for O.A. in previous 3 months (e.g., Glucosamine sulphate, Chondroitin sulphate, Diacerine piascledine) 6.
• Subjects undergone Arthroscopy or any Knee surgery during last 6 months 7.
• Pregnancy & lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Improvement in clinical sign and symptoms	8weeks
• Evaluation of pain by visual analog scale (VAS pain)	8weeks
• Western Ontario MacMaster University Osteoarthritis Index (WOMAC)	8weeks
• Radiological evolution assessed by Joint space narrowing	8weeks

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessments for safety

Trial Locations

Locations (1)

Central Research Institute of Unani Medicine (CRIUM), Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

Central Research Institute of Unani Medicine (CRIUM), Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Najmus Sehar

Principal investigator

7903422298

nsehar.ccrum@gmail.com