Clinical study to evaluate safety and efficacy of Unani formulation Safoof-e-Ziabetus Dulabi in Type 2 Diabetes Mellitus

Phase 2

Recruiting

Conditions: Type 2 diabetes mellitus without complications,

Registration Number: CTRI/2019/08/020838

Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary: Diabetes mellitus (*DhayÄbÄ«á¹us HÌ£Ärr*) refers to a group ofcommon metabolic disorders that share the phenotype of hyperglycemia. Severaldistinct types of DM exist and are caused by a complex interaction of geneticsand environmental factors. Depending on the etiology of the DM, factors contributingto hyperglycemia include reduced insulin secretion, decreased glucoseutilization, and increased glucose production. The metabolic dysregulationassociated with DM causes secondary pathophysiologic changes in multiple organsystems that impose a tremendous burden on the individual with diabetes and onthe health care system. Diabetes is one of the most challenging healthproblems of the 21st century. Type 2 DM is a significant cause of prematuremortality and morbidity related to cardiovascular disease, macrovascularcomplications, and microvascular complications in older adults. The prevalenceof diabetes is rapidly rising all over the globe at an alarming rate.

Globally, prevalence of Diabetes mellitus estimated by the IDF wasestimated to 425.0 million (8.8% of adult 20-79 years) in 2017; by 2045 thiswill rise to 629 million. The proportion of people with type 2diabetes is increasing in most countries. India alone has 72.9million and in China 114.4 million. 1 in 2 (212 million) people withdiabetes were undiagnosed. About 79% of people withdiabetes live in low and middle income countries. Thediabetes-related health expenditure will exceed from USD 727 billion (2017) toUSD 776 billion (2045). In spite of a good number of drugs developed by themodern system of medicine there are many clinical issues which are still to beaddressed like the effective control on the function of pancreas in diabetesmellitus, insulin resistance and diabetes related complications. These drugsare known to maintain the blood glucose at the required normal level and do notprevent the complications of T2DM. Further the use of these modern drugs isassociated with various adverse effects. Unani system of medicine claimsto possess a number of cost effective and safe compound and single drugs thatcan be used in management of Diabetes mellitus.

In Unani medicine, diabetes has been mentioned with differentnames like *’DhayÄbÄ«á¹us’, ’DÅ«lÄbiyya’*(water wheel),*’Diasquemus’,’Qaramis’, ’Zalq al-Majari’, ’Salas al-Bawl’, ’Zalq al-Kulya’, DawwÄriyya* (symptomsrepeated in cyclic order), *Muâ€˜aá¹á¹isha* (thirst producing)*,Atsha,* *Intesae Anmas, parkar, parkÄriyya,*,etc. *DhayÄbÄ«á¹usHÌ£Ärr*is mentioned in most of the Unani classical literaturelike Al-Qanun, Kamil al-Sanaa, Al-Hawi, etc.

After the review of Unani literature as well as recent analyticaldata, a compound unani formulation known as *Safoof-e-ZiabetusDulabi*is selected for the study.  *Sufoof - e - Ziabetes- Dulabi*(SZD) is a polyherbal Unani preparation widely prescribed for *DhayÄbÄ«á¹usSadiq* (Diabetes mellitus) and *á¸Œâ€˜uf-i-kulya* (weaknessof the kidney).The present study entitled **â€œA Randomized StandardControlled Clinical Study to Compare the Safety and Efficacy of a UnaniFormulation *Safoof-e-Ziabetus Dulabi* with Metformin in *DhayÄbÄ«á¹usHÄrr Qism ThÄnÄ«*(Type 2 Diabetes Mellitus)â€** is designedto clinically evaluate the safety and efficacy of a unani formulation *SZD*ascompared to metformin in patients with *DhayÄbÄ«á¹us HÌ£Ärr Qism ThÄnÄ«* (Type2 Diabetes Mellitus) the present study is taken for the first time andconsiders the assessment of the scientific validity of an age old, time testedUnani Pharmacopoeial formulation in *DhayÄbÄ«á¹us HÌ£Ärr Qism ThÄnÄ«.* This study is designed as aunicentric, randomized, open label, standard controlled clinical trial in patientswith *DhayÄbÄ«á¹us HÌ£Ärr Qism ThÄnÄ«* (Type 2 Diabetes Mellitus)*.*

**Composition of *Safoof-e-Ziabetus Dulabi***

***Post-e-Andrun-e-Darakht-e-Guler                           20gm***

***Gil-e-Armani                                                              10gm***

***Gulnar Farsi                                                              10gm***

***Dana Anar Shireen                                                    10gm***

***Maghz-e-Tukhm-e-Anba                                           10gm***

***Amla                                                                           10gm***

***Kishneez Khushk                                                       10gm***

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 120

Inclusion Criteria

i) Patients of any sex in the age group between 25 and 60 years ii) Fasting Plasma Glucose levels between 126 and 175 mg/dL or Post pandrial Plasma Glucose levels between 200 and 250 mg/dL (2 hours after ingestion of 75 gm of glucose in 300 ml of water) or iii)HbA1C levelâ‰¥6.5 % and iv) Presence of any of the following symptoms and signs of diabetes mellitus: 2.
Utash Mufrit(Polydipsia) 3.
Kasrat al-Bawl (Polyuria) 4.
Kasrat al-Ishtiha (Polyphagia) 5.
Bawl Layli (Nocturia) 6.
Iâ€™ya(Fatigue) 7.
Naqs al-Wazn (Loss of Weight) 8.
Sozish-e-Kaf-e-Dast-o-Pa (Burning sensation in palm and soles) 9.
Sadr (Giddiness) 10.
Naqs al-Shahwa (Loss of Libido.

Exclusion Criteria

Any of the following: 1.Subjects with fasting plasma glucose level >175 mg/dl and /or 2.Post-pandrial plasma glucose level >250 mg/dl 3.Subjects on Insulin therapy 4.Diabetes Mellitus-Type I 5.Secondary Diabetes Mellitus 6.Diabetes Mellitus associated with complications of Ketoacidosis.
7.Ischemic Heart Disease/ Hypertension/ Hyperlipidemia 8.Liver disorders 9.Impaired Renal function tests 10.Obese Subjects â€“ BMI >30 11.Pregnant and lactating women 12.Any infective disorder requiring long-term treatment 13.Drug addicts/ Alcoholics 14.Malignancy/ Epilepsy.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of Response to Therapy	At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.
Clinical assessment will be done at 2, 4, 6, 8, 10, and 12 weeks and the response to treatment will be assessed using the following parameters:	At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.
2. Decrease inHbA1c level by â‰¥1% as compared to baseline	At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.
1. Reduction in FPG and Postprandial Plasma Glucose (2-h PG) level	At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.
Improvement in symptoms of DhayÄbÄ«á¹us HÌ£Ärr Qism ThÄnÄ« (Type 2 Diabetes mellitus) on Visual Analogue Scale (VAS)	At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk.

Secondary Outcome Measures

Name	Time	Method
Haematological and biochemical assessments for safety.	i)Serious Adverse Event (SAE)

Trial Locations

Locations (1): Govt. Nizamia Tibbi College & General Hospital
🇮🇳
Hyderabad, TELANGANA, India
Govt. Nizamia Tibbi College & General Hospital
🇮🇳Hyderabad, TELANGANA, India
Dr Ghousia Tabassum
Principal investigator
8639467243
ghousia_tabassum@yahoo.com