| CTRI Number |
CTRI/2024/03/064488 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Unani
Radiation Therapy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of Efficacy and Safety of Regimenal Therapy (Wet Cupping) in the Management of Cervical Spondylosis |
|
Scientific Title of Study
|
Evaluation of Efficacy and Safety of HijÄmah-bil-Shart (Wet Cupping) in the Management of Cervical Spondylosis (Waja-ul-Unuq) |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saima Sharfuddin |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
OPD 7 , Ground Floor Department of Ilaj Bit Tadbeer
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus kolar bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8982714546 |
| Fax |
|
| Email |
saimasharfuddin29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ehsan Ahmad |
| Designation |
Assistant Professor |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
OPD 7 , Ground Floor Department of Ilaj Bit Tadbeer Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus kolar bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
7354898786 |
| Fax |
|
| Email |
ehsan.azmi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Saima Sharfuddin |
| Designation |
MD Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
OPD 7 , Ground floor Deartment of Ilaj Bit Tadbeer Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus kolar bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8982714546 |
| Fax |
|
| Email |
saimasharfuddin29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus kolar bypass Road Bhopal Madhya Pradesh 462003 |
| Type of Sponsor |
Government medical college |
|
|
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 Saima Sharfuddin |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD 7 Department of Ilaj bit Tadbeer(ground floor) Blood letting unit and Physiotherapy Unit second floor Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital
Bhopal
MADHYA PRADESH |
8982714546
saimasharfuddin29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutioal Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M199||Osteoarthritis, unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hijamah bil Shart (Wet Cupping) |
The affected site will be cleaned with antiseptic and 3 cups will be applied of different sizes for 3-4 minutes under negative pressure and then will be removed and the site will be scarified with surgical blade (no.11) and the cups will be reapplied for 5-7 minutes under negative pressure and then removed followed by cleaning of area with antiseptic and sterile dressing will be done weekly for 42days. |
| Comparator Agent |
TENS ( Transcutaneous Electrical Nerve Stimulation) |
The therapy will be done under the guidance of a Physiotherapist on the affected site weekly for 42 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having the clinical findings of cervical spondylosis such as stiffness, chronic neck weakness, radicular or non-radicular neck pain for at least three months, without acute cervical nerve root compression along with radiographic condition.
2. Patient of cervical spondylosis having no surgical indication.
3. Patients having no malignancy.
4. Patient fulfilling the inclusion criteria and agree to follow the protocol.
5. Patient providing written inform consent agree to follow protocol.
6. Patient having difficulty in comprehension.
|
|
| ExclusionCriteria |
| Details |
Hb% less than 8 gm/dl.
Patients with history of neck surgery over the past one year.
Patients having open wounds, infections on the skin where TENS or the cup application will be made.
Patients with history of inflammatory diseases involving the neck joints.
Patient having the myelopathy and known coagulopathy or on anticoagulants.
Patient having the history of fractures or dislocation of the cervical vertebrae.
Patients having central and peripheral nervous system diseases.
Pregnant women.
Patient not having good compliance with the intervention or having difficulty following the study.
Patients having active psychiatric disorders.
Patient having difficulty in comprehension. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.NPQ (Northwick park neck pain questionnaire) |
On day 0, 14, 28 and 42 . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.NPAD (Neck pain and disability scale)
2.Quality of life
3.Range of motion (Goniometer) |
On day 0, 14, 28 and 42. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
01/04/2024 |
| 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 Yet Recruiting |
| 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
|
Cervical spondylosis is defined as the osteoarthritis in the cervical spine characterized by degeneration of the intervertebral disc and osteophyte formation in which a sequence of changes takes place in the intervertebral disc, vertebral bodies and facets joints. There are three main symptom complexes related to cervical spondylosis: neck pain, cervical radiculopathy and cervical myelopathy. The management of CS in modern medicine includes pharmacological and rehabilitation components. Non-steroidal anti-inflammatory drugs, corticosteroids, analgesics, muscle relaxants, anti-convulsants and anti-depressants are frequently used in pharmacological management of the CS. The rehabilitation components include exercise oriented treatment: traction, thermal therapy, use of cervical collar, electrotherapy like ultrasound, TENS (transcutaneous electrical nerve stimulation) etc. Though the use of NSAIDs and corticosteroids etc. provide a significant symptomatic improvement on short term basis but their prolong use may cause a number of side effects. In Unani system of medicine though there is no specific term for cervical spondylosis, however, a general term Waja-ul-Mafasil is mentioned in classical text, which includes all types of musculoskeletal disorders. Cervical spondylosis literally means Waja ul Mafasil of Fiqrate Unuq, usually occurs as a result of sue mizaj barid sada and maddi; the earlier will produce non inflammatory and lateral inflammatory states of joint disease. Hijamah is one of the most popular and prescribed effective modality to be used in Waja-ul-Mafasil . Razi writes, if the humour become thick in the affected joint due to improper treatment, Hijama becomes very usefull for this condition. |