| CTRI Number |
CTRI/2020/07/026475 [Registered on: 10/07/2020] Trial Registered Prospectively |
| Last Modified On: |
06/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani
Other (Specify) [Dry cupping] |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Dry cupping in neck pain |
|
Scientific Title of Study
|
Efficacy of Hijama Bila Shart in Wajaur Raqaba - A randomized 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 |
Ayesha Tehseen |
| Designation |
PG Scholar 2nd year |
| Affiliation |
national institute of unani medicine |
| Address |
National Institute of Unani Medicine ,Main Magadi road Kottigepalaya Bangalore Karnataka
Bangalore
KARNATAKA
560091
India |
| Phone |
8970577729 |
| Fax |
|
| Email |
ayeshatehseen579@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hamid ali |
| Designation |
Assistant professor dept of ilaj bit tadbeer |
| Affiliation |
national institute of unani medicine bangalore |
| Address |
National Institute of Unani Medicine Bangalore
National Institute of Unani Medicine Bangalore
Bangalore Rural
KARNATAKA
560091
India |
| Phone |
7975301806 |
| Fax |
|
| Email |
dr.hamidali4u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hamid ali |
| Designation |
Assistant professor dept of ilaj bit tadbeer |
| Affiliation |
national institute of unani medicine bangalore |
| Address |
National Institute of Unani Medicine Bangalore
National Institute of Unani Medicine Bangalore
Bangalore Rural
KARNATAKA
560091
India |
| Phone |
7975301806 |
| Fax |
|
| Email |
dr.hamidali4u@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine |
|
|
Primary Sponsor
|
| Name |
National institute of unani medicine Bangalore |
| Address |
Main magadi road kottigepaly Bangalore |
| 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 Hamid Ali |
National Institute Of Unani Medicine |
Kottigepalya, Magadi main road, Bengaluru, Karnataka-560091
Bangalore
KARNATAKA |
7975301806
dr.hamidali4u@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 |
| Intervention |
Dry Cupping |
15 sittings of Dry Cupping for cervical spondylosis in 3 groups for 8,10,12 minutes over 7th cervical vertebrae and suprascapular region. |
| Comparator Agent |
Not Applicable |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Clinically and radiologically diagnosed patients of Wajaur Raqaba.
2) Age between 20 -60 years.
3) Either gender.
|
|
| ExclusionCriteria |
| Details |
1) History of cervical trauma or injury.
2) Concomitant skin infections, Tuberculosis and cancer at the level of cervical spine.
3) Any post healed cervical fracture.
4) All types of arthritis except osteoarthritis.
5) Increased kyphosis and lordosis.
6) Tumours (Benign or Malignant) at the level of cervical spine.
7) Any subject undergoing any systemic medical or surgical or physical therapy for cervical radiculopathy .
8) Corticosteroid use, including oral corticosteroid within 14 days, intramuscular corticosteroid within 30 days, Intra-articular corticosteroid into the study cervical region within 90 days, and ongoing use of topical corticosteroid at the site of application.
9) Cervical rib syndrome.
10) Unwillingness or inability to comply the requirements of the protocol.
|
|
|
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 |
Reduction in pain
Visual Analogue Scale (VAS) |
0th day and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck disability index(NDI) |
0th day and 15th day |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
01/08/2020 |
| 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 is a degenerative condition of cervical spine in the general population, occurs mostly in 4th and 5th decades of life.Abouttwo third of the population have neck pain at some time in their live and prevalence is highest in middle age.As neck pain affectes persons life both at home and at work,therfore relief from pain is mandatory for social , psychological, economical and medical reasons. In Unani system of medicine tje term Wajaur Raqaba is not mentioned in any clasiscal test books, but most of the eminent physicians have used a broad term Waja ul Mafasil to describe all types of joint pain. unani physicians have treated Waja ul Mafasil successfully with various drugs and regimenal modalities including hijamah bila shart, dalk, riyazat etc, hijamah bila shart is one which is commonly prescribed to evacuate Mawad e Fasida and provide relief to the patient of Waja ul mufasil. The main aim of the study is to optimize the duration of application of cups in the pain management of wajaur raqaba. Total duration of the study is 15 days ,inclusion criteria will be clinically and radiologically diagnosed patients of wajaur raqaba of 20 to 60 years of age of either gender. total 3 cups will be applied ,1 large cup over the junction of 7th cervical vertebra and 1st thoracic vertebra and 2 medium cups will be applied over the right and left supraclavicular fossa for 8,10,and 12 minutes respectively in each group .Total 15 patients will be there in each group.Any adverse reaction during therapy will be recorded and reported.The outcome will be assessed by using VAS scale and Vernon and Mior Cervical spine questionnaire. |