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
|
|
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
|
|
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). |