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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 Ḥijāma bilā shārt and AsbÄ« ŪnānÄ« 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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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, anti­inflammatory, anti-oxidants, etc. Usool-e-ilaj is Izala-e­sabab 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. 
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