| CTRI Number |
CTRI/2019/05/018946 [Registered on: 06/05/2019] Trial Registered Prospectively |
| Last Modified On: |
03/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Hijamah (Cupping)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment Of Sciatica by Hijamah(cupping) therapy |
|
Scientific Title of Study
|
"A Randomized Controlled clinical Study To Evaluate The Efficacy Of Hijamah Bil Shart in Irq-un-Nasa (Sciatica)" |
| Trial Acronym |
Sciatica |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Yaqoob |
| Designation |
MD Scholar |
| Affiliation |
JAMIA HAMDARD |
| Address |
Dept.Of Moalejat, School Of Unani Medical Education And Research,
Jamia Hamdard
New Delhi
Majeedia Unani Hospita
Jamia Hamdard
Hamdard Nagar
New Delhi
South
DELHI
110062
India |
| Phone |
9671610426 |
| Fax |
|
| Email |
yaqoobmdunani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMdWasi Akhtar |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Dept.Of Moalejat
School Of Unani Medical Education And Research
Jamia Hamdard
New Delhi
Majeedia Unani Hospita
Jamia Hamdard
Hamdard Nagar
New Delhi
South
DELHI
110062
India |
| Phone |
9027570265 |
| Fax |
|
| Email |
drwasiakhtar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Yasmeen Shamsi |
| Designation |
Professor |
| Affiliation |
JAMIA HAMDARD |
| Address |
Head Of Dept.Of Moalejat
School Of Unani Medical Education And Research
Jamia Hamdard
New Delhi
Majeedia Unani Hospita
Jamia Hamdard
Hamdard Nagar
New Delhi
South
DELHI
110062
India |
| Phone |
8750040776 |
| Fax |
|
| Email |
yshamsi@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Jamia Hamdard Hamdard Nagar New Delhi PIN-110062 |
|
|
Primary Sponsor
|
| Name |
Jamia Hamdard |
| Address |
Hamdard Nagar New Delhi PIN-110062 |
| Type of Sponsor |
Other [University] |
|
|
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 |
| Dr Mohd Yaqoob |
Majeedia Unani Hospital |
Majeedia Unani Hospital
School of Unani Medical Education and Research
Jamia Hamdard
New Delhi-110062
South
DELHI |
9671610426
yaqoobmdunani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijamah (wet cupping/ cupping with scarification) |
Group A:
Hijamah at buttock and thigh, in 3 sessions at 15 days interval |
| Comparator Agent |
Hijamah (wet cupping/ cupping with scarification) |
Group B:
Hijamah at calf muscle and ankle, in 3 sessions at 15 days interval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Already diagnosed patients of sciatica presenting with all or some of the following signs and symptoms
Unilateral leg pain greater than low back pain radiating towards leg/ foot/toes
Positive straight-leg-raising sign
Numbness and/ or tingling sensation in the same distribution
Pain intensity score of 30 -60 mm on a 100-mm visual analog scale (VAS)
Willingness to accept wet cupping intervention
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women.
Patients of previous back surgery/ lumbar spine surgery.
Patients of spinal tumors, gross/fixed developmental deformity, cauda equine or vertebral fracture
Patients of bleeding disorders
Patients of anaemia (Hb<10gm%)
Patients taking any other conservative treatment for sciatica (NSAIDS, corticosteroids, physiotherapy, acupuncture etc.)
Patients with malignancy or any liver, kidney or heart disease
Patients of of inherited neuropathy or neuropathy attributable to other causes like hypothyroidism, vitamin B12 deficiency etc.
Motor weakness/Muscle wasting
Patients suffering from Psychiatric disorders
HIV/AIDS, HCV and HBsAg positive patients
History of stroke, severe hypertension and uncontrolled diabetes mellitus
Unwilling to participate in the study |
|
|
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 |
| Relief in pain due to sciatica |
0 day, 42 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Disability and Quality of life |
0 day, 42 day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
06/05/2019 |
| 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
|
As per Jamia Hamdard guidelines |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This proposed open, randomized, prospective clinical study will be conducted on the diagnosed patients of Sciatica according to defined inclusion and exclusion criteria. 30 patients in group A and 30 patients in group B will allocated randomly. Hijamah at Warik and Fakhiz will be done in group A patients, whereas Hijamah at Saaq and Kaab will be done in group B patients on Day 0, Day 14 and Day 28. The assessment will be done on 0 day, 14th day, 28th day and 42nd day for improvement in pain, disability and quality of life. This study will validate the efficacy of Hijamah therapy in the management of Sciatica and will compare the efficacy as per the sites of Hijamah. |