| CTRI Number |
CTRI/2017/12/010929 [Registered on: 20/12/2017] Trial Registered Prospectively |
| Last Modified On: |
19/12/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study for safety and effectiveness of Unani formulation in Diabetes Mellitus |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Zayabitus Sukkari Qism Sani (Diabetes Mellitus Type 2) |
| Trial Acronym |
UNDM |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NADEEM AHMAD |
| Designation |
PG SCHOLAR |
| Affiliation |
CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD |
| Address |
DEPTT. OF MOALAJAT, CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE, OPP. ESI HOSPITAL, AG COLONY ROAD, ERRAGADDA, HYDERABAD, TELANGANA 500038
Hyderabad ANDHRA PRADESH 500038 India |
| Phone |
9616173020 |
| Fax |
|
| Email |
drnadeemcrium85@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr MOHAMMAD NAWAB |
| Designation |
READER |
| Affiliation |
CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD |
| Address |
DEPTT. OF MOALAJAT, CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE, OPP. ESI HOSPITAL, AG COLONY ROAD, ERRAGADDA, HYDERABAD, TELANGANA 500038
Hyderabad ANDHRA PRADESH 500038 India |
| Phone |
8100992044 |
| Fax |
|
| Email |
ccrumnawab@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor |
| Affiliation |
CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD |
| Address |
DEPTT. OF MOALAJAT, CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE, OPP. ESI HOSPITAL, AG COLONY ROAD, ERRAGADDA, HYDERABAD, TELANGANA 500038
Hyderabad ANDHRA PRADESH 500038 India |
| Phone |
8700027178 |
| Fax |
|
| Email |
ccrumhqrsnd58@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine, Ministry of AYUSH |
|
|
Primary Sponsor
|
| Name |
CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE HYDERABAD |
| Address |
CENTRAL RESEARCH INSTITUTE OF UNANI MEDICINE, OPP. ESI HOSPITAL AG COLONY ROAD, ERRAGADDA, HYDERABAD, TELANGANA, 500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nadeem Ahmad |
Central Research Institute of Unani Medicine |
Room No. 6 (Ground Floor) Deptt. of Moalajat, CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 Hyderabad ANDHRA PRADESH |
9616173020
drnadeemcrium85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
TYPE II DIABETES MELLITUS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active Control Drug: Metformin (Tablet) |
Patients will be given Metformin (Tablet) in the dose of one tablet (500 mg) twice daily orally with water ½ hr before meals.
|
| Intervention |
Study Drug: A Polyherbal Unani Formulation (Powder) |
Patients will be givenUnani Formulation (Powder) in the dose of 6g
twice daily orally with water ½ hr before meals.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i) Patients of any sex in the age group between18 and 65 years
ii) Fasting PlasmaGlucose levels between 126 and 150 mg/dL
or
PPPlasmaGlucoselevels between 200and 250 mg/dL
(2 hours after ingestion of 75 gm of glucose in 300 ml of water)
or
HbA1C level≥6.5 %(3) and
1. 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. I’ya(Fatigue)
7. Naqs al-Wazn (Loss of Weight)
8. Burning sensation in palm and soles
9. Sadr (Giddiness)
10. Naqs al-Shahwa (Loss of Libido)
|
|
| ExclusionCriteria |
| Details |
1. Subjects with Fasting Plasma Glucose (FPG) level >150 mg/dl and /or PostprandialPlasma Glucose level >250 mg/dl
2. Diabetes Mellitus associated with complications of Ketoacidosis
3. Diabetes Mellitus Type-I/ Secondary Diabetes Mellitus/ 4.Patients on Insulin therapy
5. Significant Pulmonary/Cardiovascular/Hepato-renal dysfunction
6. Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Response to Therapy
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:
1. Reduction in FPGand Postprandial Plasma Glucose (2-hPG) level
2. Decrease inHbA1c level by ≥1% as compared to baseline
Improvement in symptoms of ZayÄbÄ«á¹usSukkariQismSÄni(Diabetes Mellitus Type 2) on Visual Analogue Scale (VAS) |
at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assessment of Safety
2. Adverse Effects (AEs)
The adverse effects to therapy (either to test drug or control drug) will be recorded at each clinical assessment visit and also by investigations (done at week 0 and 12).
3. Haemogram: Hb%, TLC, DLC, ESR
4. LFTs: S. Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase
5. KFTs: Serum Creatinine, Blood Urea Nitrogen (BUN)
6. Urine Examination: Routine & Microscopic
|
at baseline, 2wk 4wk 6wk 8wk 10wk and 12wk |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Diabetes mellitus is a metabolic disorders of multiple etiology, characterized by hyperglycemia with disturbance of carbohydrates, fats, and protein metabolism resulting from defects in insulin secretion and insulin action. The cost of diabetes care is high and is escalating worldwide. It is estimated 673 billion USD spent due to diabetes (2). The number of people withdiabetes mellitus is increasing in every country, half of the people with diabetes mellitus do not know they have it. It is estimated by International Diabetes Federation (IDF) that193 million people with diabetes are undiagnosed and are therefore more at risk of developing complications. One in 15 adults is estimated to have glucose tolerance, and one in 7th birth is affected by gestational diabetes mellitus (GDM). Number of men was affected 215.2 million and women 199.5 million in 2015, half of the people who die from diabetes mellitus are under the age of 60 year. This disorder is frequently associated with long term complication such as atherosclerosis Ischemic Heart Disease (IHD) Chronic renal failure, diabetes ketoacidosis. Worldwide prevalence of diabetes was estimated to 415 million in 2015 but in India alone 69.1 million and in China 114 million people. On account of its complication, it is leading cause of morbidity and mortality. Due to these complications, diabetes mellitus has become global problem despite of advancement of modern science. Several anti-diabetics agents are already being used such as glibenclamide,gliclazide, glimepiride, metformin, etc. But these drugs are associated with certain side effects like purpura, disulfiram-like reaction, flu like symptoms, lactic acidosis, hepatic dysfunction. There are a number of classical compound formulations used for the management of Diabetes Mellitus in Unani system of medicine. To validate safety and efficacy of a polyherbal formulation comprising Gurmarbuti, Gilo Khushk and Maghz TukhmJamun, the present study entitled “A Clinical Study to Evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Zayabitus Sukkari Qism Sani (Diabetes Mellitus Type 2)â€has been designed. |