| CTRI Number |
CTRI/2024/02/062473 [Registered on: 09/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study effect of Regimenal therapy wet cupping in patients with sciatica. |
|
Scientific Title of Study
|
Clinical study of Irq al-Nasa (Sciatica) with therapeutic evaluation of
Hijama bil shart (wet cupping) in its management: An open-label, block
randomized, standard controlled clinical trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shameem Ahmad Rather |
| Designation |
Professor, Department of moalijat |
| Affiliation |
Regional Research Institute of Unani medicine srinagar |
| Address |
Department of Moalijat,RRIUM Naseem Bagh Campus, University of Kashmir, Srinagar, Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.SR@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shameem Ahmad Rather |
| Designation |
Professor, Department of moalijat |
| Affiliation |
Regional Research Institute of Unani medicine srinagar |
| Address |
Department of Moalijat,RRIUM Naseem Bagh Campus, University of Kashmir, Srinagar, Jammu and Kashmir
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.SR@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaweriya Damnoo |
| Designation |
PG Scholar moalijat |
| Affiliation |
Regional Research Institute of Unani medicine srinagar |
| Address |
Department of Moalijat, RRIUM Naseem Bagh Campus, University of Kashmir, Srinagar, Jammu and Kashmir
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
8899935017 |
| Fax |
|
| Email |
jaweriyadamnoo@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for research in Unani Medicine New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine New Delhi |
| Address |
Regional Research Institute of Unani Medicine (RRIUM),University of Kashmir,Srinagar, CCRUM New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 |
| Shameem Ahmad Rather |
Regional Research Institute of Unani Medicine |
Moalijat OPD-1,
Ground floor,
Department of Moalijat,
RRIUM, Naseembagh
Campus University of
Kashmir Hazratbal
Srinagar
JAMMU & KASHMIR
Srinagar
JAMMU & KASHMIR |
7889584083
shameem.rather.SR@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical Research, RRIUM Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, (2) ICD-10 Condition: M472||Other spondylosis with radiculopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijama bil shart (wet cupping therapy) |
Hijama bil shart is a unani regimenal procedure in which cupping uses suction to draw blood. the intervention will be performed on areas like kaab, Saab, fakhiz, warik. The therapy is to be done on 1st day,14day and 42nd day. |
| Comparator Agent |
tab. pregabalin |
tab pregabalin 75mg will be orally OD at bed time for 42 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 18-65 years of age.
Patients irrespective of gender.
Pain radiating to lower limb either below or above the knee.
Pain in the range of 4-10 on VAS scale
Clinically diagnosed patient of sciatica.
Willingness of the patient. |
|
| ExclusionCriteria |
| Details |
Pregnancy and lactation
Known case of spinal tumor or malignancy
Known case of Rheumatoid arthritis or metabolic bone disease
Incomplete or painful knee extension
Uncontrolled diabetes
Patients scheduled for surgery or who had previous surgery related to back
Medicolegal issues
Other con-current treatment or patients prior experience with a given treatment.
Patients suffering from bleeding disorders,anemia (severe anemia),HIV-AIDS,HepatitisB, Hepatitis C and patients on anticoagulants
Patient requiring long term treatment |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain extending from back to Anterior thigh muscles.
Radiating shooting pain from back to posterior thigh muscles
Difficulty in movement |
0day, 14day, 28day and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Straight leg raising test
Oswestry Disability Index |
0day, 14day, 28day and 42nd day |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/02/2024 |
| 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 Applicable |
| 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
|
Physicians since classical times were familiar with the malady sciatica. In the Unani system of medicine, Sciatica is known as Irq al-Nasa also known as Langdi ka dard, Rengan baw. Zakariya rhazi in his book Kitab ul mansoori mentioned that Irq al-Nasa is the pain which starts from hip and radiates to thigh, sometimes even to calf muscles and legs. The causative agents are Khilti-Dam(sanguine) or Khilt balgam ghaleez which gets accumulated in hip joint or a mixture of Khilti-balgam wa safra (phlrgm and bilious humor). It has been mentioned in book kitabul umda fil jarahat that for relieving severe pain Hijama bil shart (wet cupping) should be done. Sciatica is known as Sciatic nerve root entrapment or Sciatic nerve root pain or lumbosacral radicular syndrome or Lumbar radiculopathy. It signifies low back pain with radiation to ipsilateral leg, thereby implying pain radiating along sciatic nerve, which automatically contain fibres originating in L4-S2 roots. The prevalence of sciatica estimate vary widely 1.2-43%. Sciatica is of two types Acute and Chronic. Most common etiology of sciatica is intrusion of L4,L5 or S1 nerve that is from the herniated disk and apparent as neuropathic pain affecting one side that is extending from the gluteal region down the leg to the foot.Conventional therapies given in sciatica for treatment include Analgesics, NSAIDs, Acupuncture Traction therapy, microdisectomy etc. Thses drugs and various surgical procedures are associated with certain side effects and many complications therefore, search for safe and effective is need of on hour. Ancient physicians advocated Hijama bil shart in treatment of irq al-Nasa. |