| CTRI Number |
CTRI/2023/08/056046 [Registered on: 02/08/2023] Trial Registered Prospectively |
| Last Modified On: |
26/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation of Effect of Asbi with Methylcobalamin and Pregablin in Diabetic Peripheral Neuropathy |
|
Scientific Title of Study
|
A Clinical Study on Diabetic Peripheral Neuropathy and Comparative Evaluation of Asbi with Standard Control in its Management |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tooba Hayat |
| Designation |
Pg Scholar |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7017948219 |
| Fax |
|
| Email |
tooba.hayat.1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Tabassum Latafat |
| Designation |
Chairperson |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8218114385 |
| Fax |
|
| Email |
tabassum94tariq@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tooba Hayat |
| Designation |
Pg Scholar |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7017948219 |
| Fax |
|
| Email |
tooba.hayat.1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University Aligarh |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University AligarhUNIVERSITY |
| Type of Sponsor |
Government medical college |
|
|
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 Tooba Hayat |
Department of Moalejat |
Department of Moalejat Ajmal Khan Tibbiya College And Hospital Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH |
7017948219
tooba.hayat.1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Asbi |
2 Tablets Twice Daily For Two Months |
| Comparator Agent |
Methylcobalamine 750 Micrograms And Pregablin 75 Miligrams |
One Tablet Once A Day For Two Maonths |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinical Diagnosed Patients of Diabetic Peripheral Neuropathy With Type 2 Diabetes Mellitus Through Toronto Clinical Neuropathy Score.
Fasting Blood Sugar Less than or equal to 150 mg/dl.
HbA1c Less than or equal to 8.
Vibration Perception Test upto Moderate Loss of Vibration Perception Evaluated by Diabetic Risk Profiler.
Washout Period of 20 Days for Patients Who Were Already Taking Any Drug for Neuropathy.
Patient Willing To Participate And Follow The Instructions. |
|
| ExclusionCriteria |
| Details |
Patient below 30 Years and Above 60 Years of Age.
Physiological Status: Pregnancy and Lactation.
Pathological Status: Cardiovascular, Renal, Hepatic Diseases and Thyroid Dysfunction.
Complications of Diabetes Other Than Diabetic Peripheral Neuropathy.
Clinically Suspected Case of Neuropathy Other Than Diabetes.
Patient Having Ischemic or Neuropathic Ulcer
Alcoholic Patients.
Patients Taking Neurotoxic Drugs.
Uncontrolled Cases of Diabetes Mellitus. HbA1c > 8.
Severe Loss of Vibration Sensation. Vibration Perception Test Value > 25 Volts.
Patients Who Refuse to Give Written Consent for the Study and Who Failed to Follow up.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Vibration Perception Threshold Value
Grade 0 No Loss of Vibration Perception-Complete Improvement
Grade 1 Borderline Loss of Vibration Perception-Slight Improvement.
Grade 2 Mild Loss of Vibration Perception-Partial Improvement.
Grade 3 Moderate Loss Vibration Perception-No Improvement.
Improvement in The Score For 10 Gram Monofilament.
|
Assessment of Vibration Perception Threshold through DRP at Initiation of Study (0 Day) and at the end of Study (60 Days).
10 Milligram Monofilament Test at Initiation of the Study (0 Day) and at the end of Study (60 Days). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in the subjective parameters:
Loss of light touch & temperature sensation
Numbness & paraesthesia or both in feet & hands
Pain symptoms including burning allodynia (contact pain). |
Assessment on 0, 15, 30, 45 & 60 days. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2023 |
| 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)
|
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 and its complications have become the most important contemporary and challenging health problem worldwide. It is identified that diabetes is devastating disease that affects every part of the body, associated with both microvascular (retinopathy, nephropathy and neuropathy) and macrovascular complications (stroke, coronary heart disease and peripheral vascular disease. Diabetic neuropathy is one of the most significant microvascular and troublesome complication of diabetes mellitus, leading to great morbidity and mortality, and is imposes a considerable burden on patient’s quality of life and the health care system. Among diabetic neuropathies, diabetic peripheral neuropathy is the most common form seen in both type 1 and type 2 diabetes mellitus, and it occur 10 times more frequently than other type. It is triggered by persistent hyperglycaemia which should not be underestimated, because the progress of the disease may lead to foot ulcer, followed by gangrene that may require amputation. The reported prevalence rate of diabetic peripheral neuropathy is 10-25% Unfortunately, current therapies that reduces symptoms of diabetic peripheral neuropathy do not prevent progression of the disease. Therefore, search of safe and effective drugs for its management is quiet necessary. In Unani system of medicine, Asbi a compound formulation, used for the treatment of wajaul asab, may prove useful in this condition but its efficacy has not been evaluated so far, on scientific parameters, particularly for the management of diabetic peripheral neuropathy. Moreover, modern pharmacological treatment have side effects like nausea, vomiting, headache, blurred vision, dizziness, drowsiness, diplopia, tremors, peripheral oedema and xerostomia. Therefore, safer alternative medicine are need of hour. |