| CTRI Number |
CTRI/2020/03/024249 [Registered on: 25/03/2020] Trial Registered Prospectively |
| Last Modified On: |
17/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect Of Wet Cupping In Neck Pain |
|
Scientific Title of Study
|
Efficacy Of Hijama Bish Shart In The Pain Management Of WajaÊ» ur Raqaba (Cervical Spondylosis) - A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hina Kouser V |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine, Kottigepalya, Magadi main road, Bangalore-560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9025234062 |
| Fax |
|
| Email |
hinakouser56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Nayab |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine, Kotttigepalya, Magadi main road, Bangalore-560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9019080556 |
| Fax |
|
| Email |
nayabdr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Nayab |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine, Kottigepalya, Magadi main road, Bangalore-560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9019080556 |
| Fax |
|
| Email |
nayabdr@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine, kottigepalya, magadi main road, Bangalore-560091 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani Medicine |
| Address |
Kottigepalya, Magadi Main Road, Bangalore-560091 |
| 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 |
| Dr Mohd Nayab |
National Institute Of Unani Medicine |
Kottigepalya, magadi main road, Bangalore-560091
Bangalore
KARNATAKA |
9019080556
nayabdr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NIUM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
TENS |
Transcutaneous Electrical Nerve Stimulation
Weekly 6 Sitting for 2 weeks |
| Intervention |
Wet Cupping |
3 Sittings Of Wet Cupping For Cervical Spondylosis.
1st Sitting on nape of neck on 0 day, 2nd sitting on suprascapular region on 7th day, 3rd sitting on interscapular region on 14th day |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of Cervical Spondylosis clinically and radiologically
2. No apparent spinal deformity like- Kyphosis, scoliosis, Lordosis etc
3. VAS score for pain not less than 3
|
|
| ExclusionCriteria |
| Details |
1. Unstable, bed ridden and mentally retarded patients
2. Diabetes mellitus patient with multiple drug (more than two)
3. Other severe neurologic, psychiatric and bleeding disorders
4. Pregnant and lactating women
5. Previous history of neck trauma, cervical fracture or surgery, congenital spinal abnormality, spinal tumour and cancer
6. AIDS,HIV and HBsAG positive cases
|
|
|
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 |
| Visual Analogue Scale (VAS) |
0th day and 21st day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Neck disability index (NDI)
2. Cervical range of Motion
|
0th day and 21st day |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
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)
|
05/04/2020 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical spondylosis (WajaÊ» ur Raqaba)
is a chronic degenerative process of the cervical spine characterized by pain
in neck, degenerative changes in intervertebral disc and osteophyte formation.
Most common degenerative changes are seen in C5-C6 followed by C6-C7 and C4-C5.
About two third of the population have neck pain at some time in their live and
prevalence is highest in middle age. As neck pain affects a person’s life both at home and at work, therefore,
relief from pain is mandatory for social, psychological, economical and medical
reasons.
Though,
the use of analgesics provides significant relief in symptoms of cervical
spondylosis for a very short time, and their prolong use may induce a number of
adverse effects. Similarly, most of the patients avoid surgeries due to
complications associated with it. These ways of treatment definitely relieve
the symptoms of cervical spondylosis but not up to the mark of satisfaction and
free from adverse effects. Hence,
there is a dire need to develop a safe and effective mode of treatment for the
management of cervical spondylosis.
In UnÄni
system of medicine, the term WajaÊ» ur Raqaba is not mentioned in any
of the classical text, but most of the eminent physicians have used a broad term
Waja’ ul MafÄá¹£il to describe all types of joint pain. UnÄni
physicians have treated WajaÊ» ul MafÄá¹£il successfully
with various drugs & regimenal modalities including HijÄma Bish Shará¹,
Dalk, RiyÄá¸at etc. HijÄma Bish Shará¹ is one which is commonly
prescribed to evacuate MawÄd-i-FÄsida and to provide relief to the
patients of WajaÊ» ul MafÄá¹£il. Hence keeping the above facts in mind, I
planned a study to evaluate the effect of HijÄma Bish Shará¹ in the
management of WajaÊ» ur Raqaba entitled
as Efficacy of HijÄma Bish Shará¹ in the pain management of Waja’
ur Raqaba (Cervical Spondylosis): An Open
Label Randomized Controlled Clinical Trial is contemplated |