| CTRI Number |
CTRI/2024/04/065099 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Therapeutic evaluation and efficacy of Regimenal modality (Dry Cupping)and Unani formulation (Asbi drug) in the management of Diabetic peripheral Neuropathy |
|
Scientific Title of Study
|
Therapeutic evaluation and efficacy of ḤijÄma bilÄ shÄrt and AsbÄ« ŪnÄnÄ« formulation in the management of Diabetic Peripheral Neuropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Simran Khan |
| Designation |
MD SCHOLAR |
| Affiliation |
Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital Bhopal, (M.P.) |
| Address |
OPD No 7 depatment Of Ilaj Bit Tadbeer Ground floor of Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus Kolar Bypass Road Bhopal Madhya pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
9893934477 |
| Fax |
|
| Email |
simrankhan33049@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Arif Anees |
| Designation |
Reader |
| Affiliation |
Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital Bhopal, (M.P.) |
| Address |
OPD No 7 Depatment of Ilaj Bit Tadbeer ground floor of Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus kolar bypass road Bhopal Madhya pradesh.
Bhopal MADHYA PRADESH 462003 India |
| Phone |
7354297787 |
| Fax |
|
| Email |
arifanees110@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Simran Khan |
| Designation |
MD SCHOLAR |
| Affiliation |
Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital Bhopal, (M.P.) |
| Address |
OPD No 7 Department of Ilaj Bit Tadbeer Ground Floor of Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus kolar bypass road Bhopal Madhya pradesh
Bhopal MADHYA PRADESH 462003 India |
| Phone |
9893934477 |
| Fax |
|
| Email |
simrankhan33049@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur
|
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and College |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Aysuh campus kolar bypass road Bhopal Madhya Pradesh 462003 |
| 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 Simran Khan |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospitl |
OPD 7 Department of Ilaj bit tadbeer (ground floor)and Units of Ilaj Bit Tadbeer Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Bhopal MADHYA PRADESH |
9893934477
simrankhan33049@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hakim syed Ziaul Hasan government Unani Medical College and Hospital |
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 |
| Comparator Agent |
Asbi |
In this group patients will be treated with Asbi Drug . Patient will be subjected to take 2 tablet orally twice a day with water for 30 days.
|
| Intervention |
Asbi drug hijama bila shart |
In this group patients will be treated with Hijama Bila Shart (Dry cupping) for 10 minutes in every alternative days for 30 days.
along with patient will be subjected to take oral medication asbi drug two tablet orally Twice a day with water for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient with diabetes mellitus type 1 and type 2.stable blood glucose level less than 200mg/dl. that is HBsAg less than 9%
3. patients complain of pain in foot, burning and tingling sensation
|
|
| ExclusionCriteria |
| Details |
1. patients less than 25 years and above 60 years
2.Pregnant and lactating women
3.History of malignancy and tumour.
4.Other causes of neuropathy
5.Any spinal diseases
6.Skin lesions or skin allergy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Machigan neuropathy instrument
Vibration perception threshold |
0 day and 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain in feet
tingling and burning sensation |
every alternative days,for one month |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
15/04/2024 |
| 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 Yet Recruiting |
| 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
|
Diabetic Peripheral Neuropathy (DPN) is the most common complication of Diabetes Mellitus (DM) with a lifetime prevalence of about 50%. The prevalence of peripheral neuropathy in individuals with diabetes mellitus depends on the duration of the disease; clinically, and up to 80% of those who have had the disease for more than 15 years. Diabetic peripheral neuropathy in type 2 diabetes mellitus may affect the all part of the nervous system but most affected is symmetric neuropathy in which segmental demyelination, schwann cell injury, and axonal damage,that involves distal sensory and motor nerves. Individuals with the neuropathy develop decreased sensation in the distal extremities with less evident motor abnormalities. The loss of pain sensation can result in the development of ulcers, which heal poorly because of the diffuse vascular injury in diabetes and are a major cause of morbidity.The pathogenesis of neuropathy is unknown but it may be due to accumulation of sorbitol and fructose as a result of hyperglycaemia, leading to deficiency of myoinositol . The condition is significantly associated with age, duration of disease, daistolic blood pressure, smokers, low HDL cholesterol level and high LDL level and HBA1C . pathological feature include axonal Several types of polyneuropathies are seen in long-standing and poorly-controlled cases of DM. of both myelinated and unmyelinated fibres. With the thickening of Schwann cell basal lamina. Patchy segmental demyelination and abnormal intraneural capillaries, ( with basement membrane thickening and microthrombi) . Diabetic neuropathic pain is characterised by tingling, burning, sharp , shootingand lacinating or even as electrical shock sensations. These Features are also seen in of kidrTreatment of peripheral neuropathies should focus on the treatment of the underlying disease process. For example, glucose control in diabetic neuropathies can be with membrane stabilizers, certain anti-epileptics, and tricyclic antidepressants.FDA has approved 3 medications for the pain with DPN (Pregablin, Duloxetine, Tapentadol) but none affords complete relief In unani system of medicine the concept of diabetes neuropathy is not mentioned in classical literature but it has been described under the caption of khidr, sun hona (sunbhari), Warme asab and zofe asaab . there is related symptoms are available the pathogenesis of disease is attributed to three factors: Temperament (Mizaj), Structure (Tarkeeb) and continuity (Ittesal), abnormalities in any of these factors are considered as temperamental disarrangement (Sue Mizaj in Arabic), Structural disarrangement (Sue Tarkeeb) and discontinuity (Taffaruq e Ittesal ) respectively.According to Rhazes obstruction of nerves occur due to the accumulation of viscous substances (Imtila of Galeez Akhlat). It is said that frequent exposure of nerve to cold due to excess intake of water, excess sleep, more sexual intercourse, and taking a bath after meals, etc. can lead to the accumulation of toxic matter (fuzlat) in nerves. Ultimately, it results in weakness of nerves (Zoafe- Asaab ) and impairs nerve conduction like in Khadar. Moreover, viscous humour (Galeez Khilt) also obstructs small vessels that supply nutrients to nerves. This results in the disturbance of nerve conduction. When continuous exposure to cold accompanies with nerve weakness, it increases the chance for the dysfunction of nerves as seen in the early stage of neuropathy and with chronicity, symptoms like numbness and loss of sensation appear. Diabetic neuropathy can be treated on par with the principles of khadar along with the drugs possessing properties like a hypoglycaemic, analgesic, anesthetic, nervine tonic, antiÂinflammatory, anti-oxidants, etc. Usool-e-ilaj is Izala-eÂsabab by controlling glycemic level, Tanqiya-e-mawad by Istifragh (evacuation) and Tadil-e-mizaj by Taskheen (to provide warmth). Accordimg to unaletrature khadar or Zoafe asaab can be treated by tanqiyae mawad by hijama. Nerves are also apart of brain therefore Hijama Bila shurt will Apply on calf and ankle region. |