To evaluate the Safety and efficacy of two Unani formulations in the treatment of Gout

Phase 2

Recruiting

• Conditions: Gout, unspecified, Niqris (Gout) ,

• Registration Number: CTRI/2015/03/005610
• Lead Sponsor: Central Council for Research in Unani Medicine CCRUM New Delhi

Brief Summary

This study is designed as a multicentric open trial in patients with **Niqris (Gout).** After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically every two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 8 weeks. . Laboratory parameters for safety assessment will be conducted at baseline, first follow up and end of study.

**Composition**

**I. *MÄjÅ«n-e-SÅ«ranjÄn***

**Nameof Ingredients Botanical Name         Quantity         Actions**

1.Suranjan Shireen     (*Merendera persica*)    500 gm            Mudir-e-Bawl,Mohallil 2. Sana                                    (*Cassia angustifolia*)   250 gm           Qabiz 3. Zanjabeel                 (*Zingiber officinale*)     100 gm            Mushtahi,Hazim, Kasir-e-Riyah 4. Zeera Siyah             (*Carum carvi*)             100 gm            Hazim,Kasir-e-Riyah, Mudir-e-

Haiz,Ahtbas-e-Haiz 5. Filfil Daraz              (*Piper longum*)            100 gm            Sual,Dama, Kali Khansi 6. Asaroon                   (*Asarum europaeum*)  100 gm            Sara, Laqwa,Falij                               7. Asl Or Qand Safaid                                                3.5kg

**II.** ***Habb-e-Az******Ä******r******Ä******qi***1.  Azaraqi Mudabbar (*Strychnosnux-vomica*)           20 gm              Falij, Laqwa 2.  Filfil Siyah             (*Piper nigrum*)                        10 gm              Zof-e-Qalb, Mushtahi 3.  Filfil Daraz             (*Piper longum*)                        10 gm              Sual, Dama, Kali Khansi 4.  Arq-e-Ajwayin       (*Ptycotis ajowan*)                    Q. S.                Hazim, Kasir-e-Riyah

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-05
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• •Patients of either sex in the age group of 18-60.
• •Serum uric acid level: normal or above normal •Patients of gout having any of the following symptoms and signs: Joint Pain (especially first metatarsophalangeal (MTP) joint) Tenderness Swelling Redness.

Exclusion Criteria

•Other diseases involving small & large joints •Pregnant and lactating women •Patients having any systemic diseases such as hypertension, diabetes mellitus, Cardiovascular/Cerebrovascular diseases, hepatic and renal disease, osteomalacia, osteoporosis •Obesity (BMI: ≥ 30) •Patients on long term medications •Patients taking drugs which increase serum uric acid levels (thiazide diuretics, etc.) and decrease serum calcium levels (furosemide, etc.).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Niqris (Gout)	Improvement in signs and symptoms of Niqris (Gout)

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessment for safety assessment	12 weeks

Trial Locations

Locations (4)

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

Clinical Research Unit (CRU), Bhurhanpur; 🇮🇳 Nimar, MADHYA PRADESH, India

Regional Research Institute of Unani Medicine (RRIUM), Aligarh; 🇮🇳 Aligarh, UTTAR PRADESH, India

REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Central Research Institute of Unani Medicine (CRIUM), Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

DR SHAMSUL ARFIN

Principal investigator

05222361720

crium_lko@yahoo.co.in