| CTRI Number |
CTRI/2021/07/034986 [Registered on: 19/07/2021] Trial Registered Prospectively |
| Last Modified On: |
16/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare efficacy and safety of coded Unani formulation UNIM D 2000 with Metformin in patients with Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II) |
|
Scientific Title of Study
|
A Single blind, randomized, parallel group study to compare efficacy and safety of coded Unani formulation UNIM D 2000 with Metformin in patients with Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZS/DM/UNIMD2000/RCT/CCRUM/19-20, Version No. 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Path) SIV |
| Affiliation |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Aligarh Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM |
| Address |
Central Council for Research in Unani Medicine(CCRUM), Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Parvez Khan |
Regional Research Institute of Unani Medicine, Aligarh |
Research OPD Room (Ziabetus Sukkari Qism-e-Sani)
Post Box 70, Near Head Post Office
Aligarh
UTTAR PRADESH |
09411059371
waytoparvez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine (RRIUM), Aligarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: Ziabetus Sukkari Qism-e-Sani, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Tablet Metformin |
850 mg twice daily to be taken orally with water ½ hr after meals for 12weeks |
| Intervention |
UNIM-D 2000
|
UNIM-D 2000 (powder) 500mg Twice daily Orally with water Half hour before meals for 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender in the age group of 18-65 years
2.HbA1c level ≥ 7%
3.Both newly diagnosed and known case of Type 2 DM may be included
4.Fasting plasma glucose levels between 126 and 200 mg/dl
Or
5.2hr plasma glucose levels between 200 and 300 mg/dl
And
6.Presence of any of the following symptoms and signs of diabetes mellitus:
Utash mufrit (Polydipsia)
Kasrat al-Bawl (Polyuria)
Kasrat al-Ishtiha (Polyphagia)
Bawl Layli (Nocturia)
Iya (Fatigue)
Naqs al-Wazn (Loss of Weight)
Burning sensation in palm and soles
Sadr (Giddiness)
Naqs al-Shahwa (Loss of Libido)
Duf al Hadm
Bawl-e-raqueeque (lighter urine) with Kasrat
al-Bawl
Bawl-e-sufed (colourless urine) with Kasrat
al-Bawl |
|
| ExclusionCriteria |
| Details |
1.HbA1C ≥ 8%
2.Subjects with fasting plasma glucose level >200 mg/dl and /or PP plasma glucose level >300 mg/dl
3.Family history of Type 1 DM
4.Known cases of Metabolic syndrome
5.Diabetes Mellitus-Type 1 or subjects on Insulin therapy
6.Diabetes Mellitus associated with complications of Ketoacidosis
7.Patients on systemic corticosteroids/ disease modifying agents
8.Known cases of Ischemic Heart Disease/ Hyperlipidemia
9.Liver disorders SGPT >105 IU/L
10.Impaired renal function tests
11.Obese Subjects – BMI >35
12.Pregnant and lactating women
13.Known cases of Malignancy & Epilepsy
14.Known cases of any disorder requiring long-term treatment |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II) |
12weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
12weeks |
|
|
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 3 |
|
Date of First Enrollment (India)
|
19/05/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single centric open trial in patients with Ziabetus Sukkari Qism-e-Sani (Diabetes Mellitus Type II). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. This study is designed as a multi-centric, controlled trial in patients with DM Type II. After screening, participants will be divided into 2 arms. First arm will receive the study drug- UNIM-D 2000 Powder 5 gm BD ½ hour before meals while the second arm will receive anti-diabetic drug Metformin 850 mg B.D. The total duration of treatment will be 12 weeks. The participants will be followed once in 2 weeks for all clinical parameters. The laboratory investigations will be done at baseline, 2 weeks and last follow-up as per the CRF. Fasting Plasma Glucose and 2 Hr Plasma Glucose level will be conducted at each follow-up. Composition of Coded Unani drug UNIM D 2000 UNIM D 2000 is a compound Unani formulation containing Gurmar Buti (Gymnema sylvestris R.) Gilo (Tinospora cordifolia W.), Maghze Jamun (Syzygium cumini L.) etc. These single drugs have been described for the treatment of Ziabetus Sukkari (Diabetes Mellitus) in classical Unani literature. |