To evaluate the Safety and efficacy of Unani formulations in the treatment of Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2)

Phase 2

Recruiting

• Conditions: Type 2 diabetes mellitus without complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2) ,

• Registration Number: CTRI/2015/03/005630
• 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 Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2)  After screening, Patients will be enrolled if they satisfy  inclusion and exclusion criteria.  The patients will be assessed clinically at every two weeks.  This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 12 weeks and the follow-up for all clinical parameters will be conducted every two weeks. Laboratory parameters for safety assessment will be conducted at baseline, after two weeks and at the end of study.

**Composition of Qurs-e-Ziabetus Khaas**

 1.      Tabasheer                                            -           25g.

2.      Satt-e-Gilo                                          -           25g.

3.      Maghz-e-Khasta-e-Jamun                   -           50 g.

4.      Gurmar Buti                                        -           50 g.

5.      Kushta-e-Baiza-e-Murgh                    -           10 g.

6.      Kushta-e-Zumurrud                            -           10 g.

7.      Loab-e-Aspaghol                                -           Q.S.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Last Update Posted: 2018-03-12

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Patients of either sex in the age group of 18-65 years.
• 2.Fasting plasma glucose levels between 126 and 150 mg/dl or 3.2hr plasma glucose levels between 200 and 250 mg/dl (2 hours after ingestion of 75 gm of glucose in 300 ml of water) and/or 4.Presence of any of the following classical symptoms and signs of diabetes mellitus: •Utashmufrit (Polydipsia) •Kasrat al-Bawl (Polyuria) •Kasrat al-Ishtiha (Polyphagia) •Bawl Layli (Nocturia) •I’ya (Fatigue) •Naqs al-Wazn (Loss of Weight) •Burning sensation in palm and soles •Sadr (Giddiness) •Naqs al-Shahwa (Loss of Libido).

Exclusion Criteria

Any one of the following: •Subjects with fasting plasma glucose level >150 mg/dl and /or PP plasma glucose level > 250 mg/dl •Diabetes Mellitus-Type I •Patients on systemic corticosteroids/ disease modifying agents •Ischemic Heart Disease/ Hypertension/ Hyperlipidemia •Liver disorders SGPT >105 IU/L •Impaired Renal function •Anemia: Hb <8 gm/dl in Males and Hb <6 gm/dl in females •Obese Subjects – BMI >30 •Pregnant and lactating women •Any disorder requiring long-term treatment •Patient on any other treatment including use of alternative medicine.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in signs and symptoms of Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2)	12 weeks

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); 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Clinical Research Unit; 🇮🇳 Bangalore, KARNATAKA, India

Regional Research Centre; 🇮🇳 Allahabad, UTTAR PRADESH, India

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

Central Research Institute of Unani Medicine (CRIUM)

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Khursheed Khatoon

Principal investigator

09296653033

dr.khursheedkhatoon@gmail.com