| CTRI Number |
CTRI/2015/03/005630 [Registered on: 13/03/2015] Trial Registered Retrospectively |
| Last Modified On: |
03/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the Safety and efficacy of Unani formulations in the treatment of Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2) |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial formulation Qurs-e-Ziabetus Khaas in Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ZS/QZK/CLN VAL/CCRUM 13-14 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PROF S SHAKIR JAMIL |
| Designation |
DIRECTOR GENERAL |
| Affiliation |
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
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR K M SIDDIQUI |
| Designation |
DEPUTY DIRECTOR |
| Affiliation |
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
West
DELHI
110058
India |
| Phone |
9810161758 |
| Fax |
01128522965 |
| Email |
ccrum605@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADEEP KUMAR |
| Designation |
RESEARCH OFFICER SCIENTIST III |
| Affiliation |
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
West
DELHI
110058
India |
| Phone |
01128521981 |
| Fax |
01128522965 |
| Email |
drpradeepkumar2001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support :
1. Central Research Institute of Unani Medicine (CRIUM)
2. Regional Research Institute of Unani Medicine, Chennai
3. Regional Research Centre, Allahabad
4. Clinical Research Unit, Bangalore
Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi
|
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
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 = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Khursheed Khatoon |
Central Research Institute of Unani Medicine (CRIUM) |
AG Colony road, Erragadda
Hyderabad
ANDHRA PRADESH |
09296653033
04023811495
dr.khursheedkhatoon@gmail.com |
| Dr Najeeb Ul Hassan |
Clinical Research Unit |
NIUM, Campus, Kottigepalya, Magadi Road
Bangalore
KARNATAKA |
09886704083
crubangalore2000@yahoo.com |
| DR ZUBAIR AHMAD KHAN |
Regional Research Centre |
B- 501/4, G.T.B. Nagar ( Opp. Dulhan Place)
Allahabad
UTTAR PRADESH |
05322551808
05322655105
rrcallahabad@gmail.com |
| Hakim Hafiz C Md Aslam |
REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE |
No.1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU |
09444786772
04425955532
dr_hcmdaslam@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine, Hyderabad |
Approved |
| Regional Research Centre , Allahabad |
Approved |
| REGIONAL RESEARCH INSTITUTE OF UNANI MEDICINE, CHENNAI |
Approved |
| Clinical Research Unit, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||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) , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
na |
| Intervention |
Tablet Qurs e Ziabetus Khaas |
2 tablets Twice daily with water
Duration of therapy is 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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)
|
|
| ExclusionCriteria |
| Details |
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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in signs and symptoms of Ziabetus Sukari Qism e Sani (Diabetes Mellitus type-2) |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
02/04/2014 |
| 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) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |