| CTRI Number |
CTRI/2025/04/084318 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
TO study the effects of a compound unani formulation (Qurs-i-Kafur) in the patients of Type -2 Diabetes. |
|
Scientific Title of Study
|
Clinical study to evaluate the safety and therapeutic effects of Qurs-i-Kafur in the management of Dhayabitus Harr(Type-2 Diabetes mellitus):Randomized,Single Blind,Standard Controlled Study. |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zaffar Hussain |
| Designation |
Proffesor,Department of Moalajat |
| Affiliation |
Department of Moalajat Regional Research Institueof Unani Medicine ,Naseem bagh,University of Kashmir |
| Address |
Department of Moalajat Regional Research Institue of Unani Medicine ,Naseem bagh campus,University of Kashmir,Srinagar
Department of MoalajatRegional Research Institue of Unani Medicine ,Naseem bagh campus,University of Kashmir,Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Zaffar Hussain |
| Designation |
Proffesor,Department of Moalajat |
| Affiliation |
Department of Moalajat Regional Research Institueof Unani Medicine ,Naseem bagh,University of Kashmir |
| Address |
Department of Moalajat ,Regional Research Institue of Unani Medicine ,Naseem bagh campus,University of Kashmir,Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006021996 |
| Fax |
|
| Email |
hussainzaffar6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shugufta Hamid |
| Designation |
PG Scholar |
| Affiliation |
Department of MoalajatRegional Research Institueof Unani Medicine, University of Kashmir,SrinagarSrinaga |
| Address |
Department of Moalajat Regional Research Institueof Unani Medicine,Naseem bagh campus,University of Kashmir,Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889841736 |
| Fax |
|
| Email |
Shuguftahamid769@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine (CCRUM),New Delhi-110023,India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine (CCRUM),110058 New Delhi |
| Address |
Regional Rsearch Institute Of Unani Medicine (RRIUM), Naseem Bagh Campus,University of Kashmir,Srinagar, CCRUM,New Delhi |
| 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 |
| DrZaffar Hussain |
Regional Research Institute of Unani Medicine(RRIUM) |
Moalajat OPD-1,Ground Floor,Department of Moalajat,RRIUM,Naseem bagh Campus,University of Kashmir,Hazratbal Srinagar,Jammu and Kashmir
Srinagar
JAMMU & KASHMIR |
07006021996
hussainzaffar6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,RRium,Srinagar. |
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 |
| Intervention |
Qurs-i-Kafur 10.5 grams will be given in thre divided doses(each tablet will contain 875mg) for 90 days. |
It is a classical unani formulation taken from Al Qabadeen. The formulation comprises of 11 ingredients that is Tukhm-i-Kahu
(Lactuca sativa L)
Tukhm-i-Khurfa
(Portulaca Oleracea L)
Banslochan
(Bambosa arundinacia )
Gul-i-Surkh
(Rosa damascena Mill)
Rub-us-sus
(Ext. of Liqouris)
Gulnar
(Punica granatum L.)
Kishniz Khushk
(Coriandrum sativum L.)
Aqaqiya
(Acacia arabica)
Sandal safed
(Santalum album L)
Gil-i-Armani
(Bolus armenia)
Kafur
(Cinnamomum
Camphora).The total dose of the formulation for a day is 10.5grams which is to be given in three divided doses that is half an hour before the break fast,half an hour before lunch and half an hour before the dinner,each tablet will contain 875 mg with Ab-i-anar Tursh. |
| Comparator Agent |
Tablet Metformin 500mg twice a day |
Tablet Metformin 500 mg to be given twice a day that is half an hour before the breakfast and half an hour before the dinner with lukewarm water for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group between 18-70 years
2) Patients irrespective of gender
3) Fasting plasma glucose levels between 126-150 mg/dl OR
4) 2-hour post-prandial plasma glucose level between 200-250 mg/dl OR
5) HbA1c level between 6.5-8%
|
|
| ExclusionCriteria |
| Details |
1) Pregnant and lactating mothers.
2) Subject with the fasting glucose level more than 150 mg/dl
3)Post-prandial glucose level more than 250 mg/dl
4) HbA1c more than 8
5) Subjects on insulin therapy
6) Known cases of Type-2 Diabetes mellitus with complications of ketoacidosis, Diabetic Nephropathy, Diabetic retinopathy
7) Known cases of Type-1 Diabetes mellitus / Gestational Diabetes mellitus
8) Known cases of significant pulmonary, cardio-vascular, hepato- renal dysfunction
9) Uncontrolled hypertension
10) Known cases of polycythemia, iron deficiency aneamia, hemoglobinopathies
11) Patient not willing to attend treatment schedule regularly
12)Patients on double or triple combination therapy for Type-2 Diabetes mellitus
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)HbA1C
2)Fasting blood glucose levels
3)2-Hour PPBG levels
4)Fasting urine for glucose and ketones estimation
5)Mean blood glucose levels |
1)HbA1C (At baseline And 91ist day of the Study)
2)Fasting blood glucose levels(at baseline,15th,30th,45th,60th,75th and 91ist day of the study )
3)2-Hour PPBG levels(At baseline,15th day,30th day,45th day,60th day,75th day and 91ist day of the study)
4)Fasting urine for glucose and ketones estimation (At baseline and 91ist day of the study)
5)Mean blood glucose levels(At Baseline and 91ist day of the study) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A)Arbitary scale for the evaluavation of the subjective parameters which include
1)Polydypsia
2)Polyuria
3)Polyphagia
4)Loss of weight
5)Loss of libido
6)Giddiness
7)Nocturia
8)Fatigue
9)Burning sensation in palms and soles
10)VAS for the Pain
B)Lipid ProfiLe,CBC with ESR,LFT,KFT,Na+,K+ and ECG
C)Assessement of Quality of life with MDQoL-17 |
A)Subjective parameters are to be evaluated at baseline,15th,30th,45th,60th,75th and 91ist day
B) Lipid Profile,CBC with ESR,LFT,KFT,Sodium, potassium and ECG at the baseline and 91ist day of the study.
C)Assessement of Quality of life with MDQoL-17 at baseline and 91ist day. |
|
|
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)
|
20/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes mellitus refers to a group of common metabolic disorders that shares the phenotype of hypergiycemia.Several distinct tyoes of Diabetes mellitus are caused by the complex interaction of genetics and environmental factors.Diabetes is a major health issue that has reached alarming levels.Today more than half a billion people are living with the Diabetes mellitus and it is one of the fastest growing global health emergencies of 21th century.The increased prevalence of the disease together with it’s complications like end stage renal disease,non -traumatic lower extremity amputations,adult blindness and many more make diabetes a nasty disease,as these complications lead to the increased morbidity,disability,mortality and present a great threat for the economies of all the countries especially the developing ones .Therefore it the need of an hour to bring the altrenative medicine into the practice,so that a safer and effective way of treatment can be established.Our Unani scholars have discribed Diabetes in various unani books and a number of single and compound formulations have been used by them which include,Tukhm-i-Hulba,Kalonji,Aqaqiya,Gul-i-surkh.Qurs-i- Dhayabitus,Qurs -i-Tabasheer,Qurs-i-Gulnar,Safoof-i-Hindi etc .In addition to this,one of the drugs that has been mentioned in the Unani texts,is Qurs-i-Kafur,hence this trail titled as Clinical study to evaluvate the safety and efficacy of Qurs-i-Kafur, in the management of Dhayabitus Harr ( Type -2 Diabetes mellitus) a randomized single blind standard controlled study has to be conducted to evaluate the Qurs-i-kafur,on the scienticfic parameters |