| CTRI Number |
CTRI/2022/10/046705 [Registered on: 21/10/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Diabetes mellitus and its management with unani medicine |
|
Scientific Title of Study
|
Clincal study of ziabetes-e-shakari(Diabetes mellitus type II) and its management with unani medicine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRSHAIKH ATEEQUR RAHMAN |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL |
| Address |
OP NO. 122 GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL CHARMINAR HYDERABAD
OP NO. 228 GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL CHARMINAR HYDERABAD
Hyderabad
TELANGANA
500002
India |
| Phone |
9595426262 |
| Fax |
|
| Email |
ateequrrahman65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRMA FAROQUI |
| Designation |
PROFESSOR AND HOD GENERAL MEDICINE |
| Affiliation |
GOVT NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL |
| Address |
OP NO 122 GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL CHARMINAR HYDERABAD
OP NO 213 PG DEPARTMENT OF MOALEJAT(GENERAL MEDICINE)
Hyderabad
TELANGANA
500002
India |
| Phone |
9849139356 |
| Fax |
|
| Email |
dr.faroqui@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DRSHAIKH ATEEQUR RAHMAN |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL |
| Address |
OP NO. 122 GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL CHARMINAR HYDERABAD
OP NO 228 PG DEPARTMENT OF MOALEJAT (GENERAL MEDICINE)
Hyderabad
TELANGANA
500002
India |
| Phone |
9595426262 |
| Fax |
|
| Email |
ateequrrrahman65@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG DEPARTMENT OF MOALEJAT (GENERAL MEDICINE) ,
GOVT NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL,HYD. |
|
|
Primary Sponsor
|
| Name |
PG DEPARTMENT OF MOALEJAT GENERAL MEDICINE GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL |
| Address |
GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL CHARMINAR HYDERABAD |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| GOVTNIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL |
CHARMINAR HYDERABAD TELANGANA STATE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SHAIKH ATEEQUR RAHMAN |
GOVT.NIZAMIA TIBBI COLLEGE AND GENERAL HOSPITAL |
OP NO. 122 PG DEPARTMENT OF MOALIJAT (GENERAL MEDICINE)
Hyderabad
TELANGANA |
9595426262
ateequrrahman65@gmail.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, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NILL |
NILL |
| Intervention |
Unani drugs Gymnema sylvestre(3 grams)
Trigonella foenum graecum(3 grams) |
6 grams of powder to be given per oral twice daily with water before meal for 40 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.HBA1C 6.5gm% TO 7.5gm%
2.DIABETIC NEUROPATHY
3.FBS 120 TO 160mg/dl
4.PLBS 180 TO 300 mg/dl |
|
| ExclusionCriteria |
| Details |
1.TYPE 1 DIABETES
2.PREGNANT AND LACTATING WOMEN
3.DIABETES WITH CARDIOVASCULAR DISEASE
4.DIABETES WITH RENAL DISORDER
5.MALIGNANCY
6.DIABETIC KETOACIDOSIS
7.SUBJECTS ON INSULIN THERAPY |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
TO ACHIEVE THE BLOOD GLUCOSE LEVELS IN NORMAL RANGE.
i.e FBS - 70 TO 110.
PLBS- 120 TO 180 |
EVERY 10 th DAY FOR 40 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DECREASE IN SYMPTOMS OF POLYDIPSIA, POLYPHAGIA, POYURIA |
EVERY 10 th DAY FOR 40 DAYS |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
25/10/2022 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NILL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
.
Diabetes mellitus is a heterogeneous group condition with disordered metabolism
& inappropriate hyperglycemia due to either a deficiency of insulin
secretion or to a combination of insulin resistance and inadequate insulin
secretion. Giving rise to microvascular damage (Retinopathy, Nephropathy,
Neuropathy).
. The term Diabetes was first coined by Araetus Cappodocia.
Later mellitis(honey
sweet) addedbt
Thomas Willis.
. ZIABETES is Greek word which means “ to run
through †or siphon.
. There are
estimated 72.96 million cases of diabetes in adult population of India.
(INDIAB Study)10-oct-2019.
UNANI CONCEPT: Su-e-Mizaj Haar Gurda(Hot derangement in temperament
of kidney): Økidneys absorbs water from circulation
due to excessive hotness or derangement in temperament. Therefore they can’t
retain much amount of fluid & pass in the form of urine. (frequently
polyuria) to overcome the thirst. (AL-QANOON) Su-e-Mizaj Barid Gurda(cold derangement in temperament
of Kidney):
Ø sometimes excessive exposure of cold to kidney
leads to sue mizaj barid
develops diabetes.
MODERN CONCEPT:
üAccording to
modern concept,
diabetes mellitus is heterogenous metabolic disorder characterized by hyperglycemia with disturbance of
carbohydrate, fat and protein metabolism.
üInadequate
insulin secretion, increase glucose production,
tissue resistance to insulin or combination of any of these.
üGenetic
& environmental factors combine to cause both insulin resistance & beta
cell loss.
üIncidence
of T2DM is Rising due to rising obesity
and reduced activity levels.
ENTRY OF GLUCOSE INTO THE CELL:
.
Glucose concentration in cell< Plasma (less than 100mg/dl)
.
Doesn’t enter by simple diffusion
1.Insulin
independent transport system of glucose:
Hepatocytes,
RBC, Brain
2.Insulin
dependent transport system of glucose :
Muscle
& adipose tissue
GLUT2
GLUT4
Deficency of
GLUT4 results insulin resistance.
SIGN AND SYMPTOMS: üSAL-A-SUL BAUL (POLYURIA) üATASH MAFRAT (POLYDIPSIA) üPOLYPHAGIA üUNEXPLAINED WEIGHT
LOSS üCHRONIC
SKIN INFECTION LIKE PRURITIS, VAGINITIS
INVETIGATION: FBS PLBS HBA1C C-PEPTIDE
REFERENCES: üSHARAH-E-ASBAB BY ALLAMA NAJEEBUDDIN SAMARQANDI TRANSALTED BY HAKEEM ALLAMA MOHAMMED KABEERUDDIN Page; 29-35
üKITABUL HAWI FIT-TIB BY ZAKARIA RAZI VOL 10 Page:181-194
üKITAB AL-AKSEER BY ALLAMA HAKEEM MOHAMMED KABEERUDDIN VOL.2 Page:1195
üKAMILUS-SANAT BY ABUL HASAN ALI IBN ABBAS MAJOOSI URDU TRANSALATION BY HAKEEM GHULAM HUSSAIN VOL.2 Page ; 469
üZAKHEERA-E-KHWARZAM
SHAHI by AHMED ALHASAN AL-JARJANI Translation by Hakeem hadi HUSSAIN KHAN
(IDARA KITABUSH SHIFA DARYA GANJ NEW DELHI) page no. 540,541
üAL
QANON FIT TIB by SHAIKH UR RAEES BU ALI IBN
SINA (IDARA KITABUSH-SHIFA DARYA GANJ DELHI) Page:248,249,250
üHAAZIQ
by HAKEEM MOHAMMED AJMAL KHAN (IDARA KITABUSH SHIFA DELHI) Page 387
üHARISON’S
Vol.2 17th,
edition page 2275,2278
üDAVIDSON’S
Edition 20th Page
:805
üMACLEODS
CLINICAL EXAMINATION 12TH
Edition page:94,95
üCURRENT
MEDICAL DIAGNOSIS
AND TREATMENT EDITION 2017
Page:121 üINDIAN
MATERICA MEDIA (DR.KM NADKARNI’S) VOL.1 Page;596 AL- -AKSEER
HAKEEM MOHAMMED AZAM KHAN TRANSLATION BY HAKEEM MOHAMMED KABEERUDIN Page:818
|