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CTRI Number  CTRI/2021/02/031581 [Registered on: 26/02/2021] Trial Registered Prospectively
Last Modified On: 10/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   sciatica treatment through venous blood letting from leg vessels. 
Scientific Title of Study   Efficacy of FasÌ£d (venesection) in the management of ‘Irqunnasā (Sciatica) - A Randomized Controlled Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Zaheer Ahmad 
Designation  P.G. Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Dept.of Ilaj Bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore-560091
Dept. of Ilaj Bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore-560091
Bangalore
KARNATAKA
560091
India 
Phone  8882764440  
Fax    
Email  zaheerfaiz09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Abdul Azeez 
Designation  Assistant Professor 
Affiliation  National Institute of Unani Medicine 
Address  Dept.of Ilaj Bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore
Dept. of Ilaj Bit Tadbeer, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore
Bangalore
KARNATAKA
560091
India 
Phone  8618858677  
Fax    
Email  aafaris@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abdul Azeez 
Designation  Assistant Professor 
Affiliation  National Institute of Unani Medicine 
Address  Dept. of Ilaj Bit Tadbeer, National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore-
Dept. of Ilaj Bit Tadbeer, National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore-
Bangalore
KARNATAKA
560091
India 
Phone  8618858677  
Fax    
Email  aafaris@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine NIUM 
 
Primary Sponsor  
Name  National Institute of Unani Medicine NIUM 
Address  National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore-560091  
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 
Dr Abdul Azeez  Hospital National Institute of Unani Medicine  Kottigepalya, Magadi Main Road, Bangalore-560091
Bangalore
KARNATAKA 		 8618858677

aafaris@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M543||Sciatica,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fasd (Venesection)  Venesection of the sciatic vein of the affected side. 
Comparator Agent  TENS  Transcutaneous Electrical Nerve Stimulation (TENS) will be given on Alternate days for 28 days. Site : Lower back and course of sciatic nerve Electrode placement : Cross pattern Rate: 50-100 Hz delivered in bursts, of 1-4 pulses per second Intensity : Comfortable with intermittent tingling sensation Duration of procedure : 20 minutes per sitting Pulse shape :Asymmetrical biphasic  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Clinically diagnosed cases of ‘Irqunnasā (SLR 30-70ï‚°)15
2. Pain in the range of 4 to 9 on VAS.
3. Both genders
4. Patients between 20 to 55 years of age
5. Hb13gm/dl or more
6. Patients willing to take part in the study
 
 
ExclusionCriteria 
Details  1. who fail to give consent for the trial and follow up
2. Pregnancy, Lactation
3. Systemic illness e.g. cancer, liver, kidney, cardiac and pulmonary diseases
4. Bleeding tendencies
5. Hypotension (Below 100/60mmHg)
6. Spinal injury or deformity (Congenital / Acquired)
7. Any orthopedic condition of hip joint restricting gait and movement
8. Patients Positive cases of HIV or HBsAg
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Straight Leg Raising Test
2 VAS (visual analogue scale)
 		 14th day

28th day
 
 
Secondary Outcome  
Outcome  TimePoints 
1 ODI (Oswestry Disability Index)16
2 SBI (Sciatica Bothersomeness Index)
 		 0 day
7th day
14th day
21st day
28th 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 2 
Date of First Enrollment (India)   01/03/2021 
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   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Sciatica refers to pain or discomfort associated with sciatic nerve. Injury to or pressure on the sciatic nerve can cause the characteristic pain of sciatica: a sharp or burning pain that radiates from the lower back or hip, possibly following the path of the sciatic nerve to the foot. It is one of the commonest neuralgic pain creating difficulty and problems in activities of daily living. The overall incidence of this condition is approximately between 13- 40 % and the malady has the potential to become chronic and intractable with major socioeconomic implication.Sciatica is usually treated by the conventional therapies either pharmacologically or surgically or sometimes, both. these therapies are associated with certain side effects and complications; therefore, search for a safe and effective regimen is the need of the hour. There is a disease in Unani system of medicine known as ‘Irqunnasā its signs and symptoms mimick almost completely with sciatica. Hence, any approach for treating ‘Irqunnasā will also be beneficial for sciatica. For ‘Irqunnasā there are a no. of different kinds of regimens given  which are more effective with less adverse effects and at the same time cost effective like HÌ£ijāma (Cupping), Irsāl-i-‘Alaq (Leech therapy), Dalk (massage), Ä€bzan (Sitz Bath) and  FasÌ£d (Venesection). Almost all great Unani physicians advocated FasÌ£d in the treatment of ‘Irqunnasā . Therefore, it is high time to evaluate the efficacy and safety of FasÌ£d in the  management  of ‘Irqunnasā.   
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