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CTRI Number  CTRI/2019/07/020046 [Registered on: 05/07/2019] Trial Registered Retrospectively
Last Modified On: 03/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Other 
Public Title of Study   Treatment of Sciatica with Wet Cupping ( Hijama-bil-Shart  
Scientific Title of Study   Effect of HijamaBishShart(wet cupping) and Zimad-i-Pudina in Irqunnasa(sciatica):A Comparative Clinical study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sajid Habib 
Designation  PG Sholar 
Affiliation  National institute of Unani Medicine 
Address  NIUM campus Boys Hostel Room No 11 kotigepalya Magadi main road
NIUM kotigepalya Magadi main road
Bangalore
KARNATAKA
560091
India 
Phone  7411684634  
Fax    
Email  sajihabib1153@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abdul Aziz Faris 
Designation  Lecturer 
Affiliation  National institute of Unani Medicine 
Address  NIUM kotigepalya Magadi main road
NIUM campus Boys Hostel Room No 11 kotigepalya Magadi main road
Bangalore
KARNATAKA
560091
India 
Phone  9035417278  
Fax    
Email  aafaris@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abdul Aziz Faris 
Designation  Lecturer 
Affiliation  NIUm 
Address  NIUM kotigepalya Magadi main road
NIUM campus Boys Hostel Room No 11 kotigepalya Magadi main road

KARNATAKA
560091
India 
Phone  9035417278  
Fax    
Email  aafaris@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine 
 
Primary Sponsor  
Name  NIUm 
Address  NIUM kotigepalya Magadi main road 
Type of Sponsor  Research institution and hospital 
 
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 
Sajid Habib  NIUM Hospital  OPD # 28, Department of IBT, NIUM Hospital Kotigepalya magadi main road
Bangalore
KARNATAKA 
7411684634

sajidhabib1153@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the institutional Ethics Committee (IEC) for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M543||Sciatica,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hijama Bish Shart and Zimad-i-pudina  Hiram Bish Shart with Zimad-i-Pudina 
Comparator Agent  TENS  TENS at 0, 15th and 30th day 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Clinically diagnosed cases of Irqunnasa(Sciatica)
• Patients of either gender
• Patient between 20-60 years of age
• Weight more than 45 kg
• Willingness to participate in the study and follow the instruction
 
 
ExclusionCriteria 
Details  • Pregnant woman & lactating mother
• Spinal injury or deformity (congenital/acquired)
• Any orthopaedic condition of hip joint restricting gait & movement
• Systematic illness i.e. liver, kidney, cardiac, & pulmonary disease
• Uncontrolled Diabetes mellitus, Severe Hypertension, bleeding disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Straight Leg Raising Test
•VAS (10 Points Likert’s Scale)
•ODI (Oswestry Disability Index)
•SBI (Sciatica Bothersomeness Index)
 
0, 15th, 30th 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in QoL  30th day 
 
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   Phase 4 
Date of First Enrollment (India)   25/03/2018 
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)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The term ‘Sciatica’ describes a symptom i.e, pain along the sciatic nerve pathway, rather than a specific condition, illness, or disease. It is generally caused by compression of lumbar nerve L4 or L5 or S1, S2, or S3 or by compression of sciatic nerve itself.  Pain typically occurs in the distribution of a dermatome & goes below the knee to the foot. It may be associated with neurological dysfunction, such as weakness . The pain is characteristically of a shooting type, quickly travelling along the course of the nerve.

It is one of the commonest neuralgic pain creating difficulty & problem in activities of daily living. 2%-40% of people havesciatica at some point of time .It is most common during the age of 40s &50s and men are more frequently affected than women.

Despite of advancement, there is no specific treatment approach in modern system of medicine. The condition is managed by bed rest, physical therapy (directed exercise), opoids, muscle relaxants, NSAIDS, botulinum toxin injection, steroids, gabapentin, TENS, Surgery (disectomy) and alternative medicine.

In Unani system of medicine, Irqunnasa (sciatica) & its treatment has been describe by many physicians. According to Jalinoos(Galen), in Irqunnasa(sciatica) the morbid matter get accumulated in the joint. Therefore cupping will be beneficial for the same. According to IbneSina, prior to evacuation of morbid matter, strong purgatives should be avoided. Emesis is better than purgation, in addition anti-inflammatory ointment (Zimad) & irrigation can be used. In case, the condition remained unresolved wet cupping (Hijama) and Zimad can employed after mild laxatives. Keeping all these things in view, study l is  planned to evaluate  the  effect of Hijama BishShart (wet cupping) and Zimad-e-Pudina in the patients of  Irqunnasa(sciatica).

Almost all ancient Unani physicians  advocated  HijamaBishShart(wet  cupping) in the treatment of Irqunnasa (sciatica).Therefore,it is high time to evaluate the effect  of  HijamaBishShart (wet cupping) in the  management  of Irqunnasa(sciatica). 
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