CTRI Number |
CTRI/2019/08/020838 [Registered on: 22/08/2019] Trial Registered Prospectively |
Last Modified On: |
06/09/2020 |
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 to evaluate safety and efficacy of Unani formulation Safoof-e-Ziabetus Dulabi in Type 2 Diabetes Mellitus
|
Scientific Title of Study
|
“A Randomized Standard Controlled Clinical Study to Compare the Safety and Efficacy of a Unani Formulation Safoof-e-Ziabetus Dulabi with Metformin in DhayÄbÄ«á¹us HÄrr Qism ThÄnÄ« (Type 2 Diabetes Mellitus)†|
Trial Acronym |
T2DM |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ghousia Tabassum |
Designation |
Ph.D Scholar |
Affiliation |
Jamia Millia Islamia , New Delhi |
Address |
PG Dept. of Moalajat, Govt. Nizamia Tibbi College,
Charminar,
Hyderabad.
Hyderabad TELANGANA 500002 India |
Phone |
8639467243 |
Fax |
|
Email |
ghousia_tabassum@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr M A Faroqui |
Designation |
Professor |
Affiliation |
Govt. Nizamia Tibbi College |
Address |
PG Dept. of Moalajat,
Govt. Nizamia Tibbi College,
Charminar,
Hyderabad.
Hyderabad TELANGANA 500002 India |
Phone |
8309160124 |
Fax |
|
Email |
drfaroqui@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Prof Dr M A Faroqui |
Designation |
Professor |
Affiliation |
Govt. Nizamia Tibbi College |
Address |
PG Dept. of Moalajat,
Govt. Nizamia Tibbi College,
Charminar,
Hyderabad.
Hyderabad TELANGANA 500002 India |
Phone |
8309160124 |
Fax |
|
Email |
drfaroqui@gmail.com |
|
Source of Monetary or Material Support
|
Central Council for Research in Unani Medicine |
|
Primary Sponsor
|
Name |
Central Council for Research in Unani Medicine |
Address |
61-65, Institutional Area, Opp. D-Block, Janakpuri, New Delhi, Delhi 110058 |
Type of Sponsor |
Government funding agency |
|
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 Ghousia Tabassum |
Govt. Nizamia Tibbi College & General Hospital |
OPD Room No:2, Moalajat, OPD Block, near Charminar, Hyderabad 500002. Hyderabad TELANGANA |
8639467243
ghousia_tabassum@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical committee |
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, |
|
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. For a duration of 12 weeks |
Intervention |
Study Drug: Safoof-e-Ziabetus Dulabi |
Patients will be given Safoof-e-Ziabetus Dulabi (Powder) in the dose of 6g twice daily orally with water ½ hr before meals. For a duration of 12 weeks. |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
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 level≥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. I’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 |
|
ExclusionCriteria |
Details |
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 – BMI >30
11. Pregnant and lactating women
12. Any infective disorder requiring long-term treatment
13. Drug addicts/ Alcoholics
14. Malignancy/ Epilepsy
|
|
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 FPG and Postprandial Plasma Glucose (2-h PG) level
2. Decrease inHbA1c level by ≥1% as compared to baseline
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
|
Outcome |
TimePoints |
Haematological and biochemical assessments for safety.
i)Serious Adverse Event (SAE)
ii)Adverse Event / Adverse Drug Reaction (AE/ADR)
iii)Laboratory Abnormalities as AEs
Haemogram, Liver Function Test(LFT), Kidney Function Test(KFT), Lipid profile, Thyroid profile, Complete Urine Examination (CUE): Routine & Microscopic, Erythrocyte Sedimentation Rate(ESR), Electrocardiogram(ECG)
|
The adverse effects to therapy (either to test drug or control drug) will be recorded at each clinical assessment visit i.e At baseline, 2wk, 4wk, 6wk, 8wk, 10wk and 12wk and also by investigations (done at week 0 and 12).
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
26/08/2019 |
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)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
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 (DhayÄbÄ«á¹us HÌ£Ärr) refers to a group of
common metabolic disorders that share the phenotype of hyperglycemia. Several
distinct types of DM exist and are caused by a complex interaction of genetics
and environmental factors. Depending on the etiology of the DM, factors contributing
to hyperglycemia include reduced insulin secretion, decreased glucose
utilization, and increased glucose production. The metabolic dysregulation
associated with DM causes secondary pathophysiologic changes in multiple organ
systems that impose a tremendous burden on the individual with diabetes and on
the health care system. Diabetes is one of the most challenging health
problems of the 21st century. Type 2 DM is a significant cause of premature
mortality and morbidity related to cardiovascular disease, macrovascular
complications, and microvascular complications in older adults. The prevalence
of diabetes is rapidly rising all over the globe at an alarming rate.
Globally, prevalence of Diabetes mellitus estimated by the IDF was
estimated to 425.0 million (8.8% of adult 20-79 years) in 2017; by 2045 this
will rise to 629 million. The proportion of people with type 2
diabetes is increasing in most countries. India alone has 72.9
million and in China 114.4 million. 1 in 2 (212 million) people with
diabetes were undiagnosed. About 79% of people with
diabetes live in low and middle income countries. The
diabetes-related health expenditure will exceed from USD 727 billion (2017) to
USD 776 billion (2045). In spite of a good number of drugs developed by the
modern system of medicine there are many clinical issues which are still to be
addressed like the effective control on the function of pancreas in diabetes
mellitus, insulin resistance and diabetes related complications. These drugs
are known to maintain the blood glucose at the required normal level and do not
prevent the complications of T2DM. Further the use of these modern drugs is
associated with various adverse effects. Unani system of medicine claims
to possess a number of cost effective and safe compound and single drugs that
can be used in management of Diabetes mellitus.
In Unani medicine, diabetes has been mentioned with different
names like ’DhayÄbÄ«á¹us’, ’DÅ«lÄbiyya’ (water wheel), ’Diasquemus’,
’Qaramis’, ’Zalq al-Majari’, ’Salas al-Bawl’, ’Zalq al-Kulya’, DawwÄriyya (symptoms
repeated in cyclic order), Mu‘aá¹á¹isha (thirst producing),
Atsha, Intesae Anmas, parkar, parkÄriyya, ,etc. DhayÄbÄ«á¹us
HÌ£Ärr is mentioned in most of the Unani classical literature
like Al-Qanun, Kamil al-Sanaa, Al-Hawi, etc.
After the review of Unani literature as well as recent analytical
data, a compound unani formulation known as Safoof-e-Ziabetus
Dulabi is selected for the study. Sufoof - e - Ziabetes
- Dulabi (SZD) is a polyherbal Unani preparation widely prescribed for DhayÄbÄ«á¹us
Sadiq (Diabetes mellitus) and Ḍ‘uf-i-kulya (weakness
of the kidney).The present study entitled “A Randomized Standard
Controlled Clinical Study to Compare the Safety and Efficacy of a Unani
Formulation Safoof-e-Ziabetus Dulabi with Metformin in DhayÄbÄ«á¹us
HÄrr Qism ThÄnÄ« (Type 2 Diabetes Mellitus)†is designed
to clinically evaluate the safety and efficacy of a unani formulation SZD as
compared to metformin in patients with DhayÄbÄ«á¹us HÌ£Ärr Qism ThÄnÄ« (Type
2 Diabetes Mellitus) the present study is taken for the first time and
considers the assessment of the scientific validity of an age old, time tested
Unani Pharmacopoeial formulation in DhayÄbÄ«á¹us HÌ£Ärr Qism ThÄnÄ«.
This study is designed as a unicentric, randomized, open label, standard controlled clinical trial in patients
with 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 |