| CTRI Number |
CTRI/2021/03/032263 [Registered on: 24/03/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of habb waja ul mafasil in management of Cervical Spondylosis |
|
Scientific Title of Study
|
Clinical study of Cervical Spondylosis (waja al-Unuq) with therapeutic evaluation and safety of Habb Waja al Mafasil in its management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Safia husain |
| Designation |
PG Scholar |
| Affiliation |
Regional Research Institute of Unani Medicine, Srinagar |
| Address |
Department of Moalijat,RRIUM,Naseem bagh campus, University of Kashmir , Hazratbal Srinagar
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
9045992355 |
| Fax |
|
| Email |
safiahusain5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shameem Ahmad Rather |
| Designation |
Reader |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalijat RRIUM, Naseem bagh campus, University of Kashmir, Hazratbal Srinagar
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shameem Ahmad Rather |
| Designation |
Reader |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalijat RRIUM, Naseem bagh campus, University of Kashmir, Hazratbal Srinagar
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for research in unani medicine (CCRUM), New dehli. |
|
|
Primary Sponsor
|
| Name |
Central council for research in Unani medicine New dehli |
| Address |
Regional Research Institute of Unani Medicine RRIUM university of Kashmir Srinagar |
| 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 |
| Safia husain |
Regional Research Institute of Unani Medicine, Srinagar |
Moalajat OPD-2 Ground floor Department of moalajat RRIUM naseembagh campus University of Kashmir hazratbal Srinagar Srinagar JAMMU & KASHMIR |
9045992355
safiahusain5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, RRIUM, Srinagar |
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 |
Habb Waja ul mafasil |
ingredients: Sibr(140gms), halela zard(35gms), suranjan(35gms), saqmooniya(17.5gms)
method of prepration:
all the above ingredients will be grounded to fine powder and are doughed with abe makoh and pills are made
Dose: 3 tablets twice a day after meals
Route of administration: oral
duration of study:30 days
|
| Comparator Agent |
Ibuprofen 400mg |
400mg of ibuprofen will be given orally thrice a day after meals for 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
-Patients between 20 and 70 years of age.
-Male, Female and transgender
-Clinically diagnosed patients of cervical spondylosis
-Patients who have agreed to sign the informed consent form and follow up the protocol |
|
| ExclusionCriteria |
| Details |
Patients below 20 and above 70 years.
Trauma
Local wound and infection over neck.
Psychomotor syndrome
Patients with history of systemic diseases like, diabetes, cardiovascular diseases, impaired renal and hepatic functions, HIV, T.B and COPD.
Patients who refuse to give the written consent for the study.
Pregnancy and lactating women.
Any of them not covered under inclusive criteria. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relief in signs and symptoms of cervical spondylosis |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological,biochemical and radiological assessment |
30 days |
|
|
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)
|
30/03/2021 |
| 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
|
01 |
|
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 spinal canal and neural foraminal narrowing in cervical spine secondary to multifactorial degenerative changes. This is one of the most common degenerative disorders of the spine affecting 95% of patients by the age of 65 years. The majority of people with spondylosis are asymptomatic. Patients who are asymptomatic tend to be older than 40 years and present with 3 types of symptoms neck pain, cervical radiculopathy and/or cervical myelopathy. The neck pain is either acute or chronic and often without identifiable precipitating event. Cervical spondylosis stands for degenerative arthritis, osteoarthritis of the cervical vertebrae and related tissues. It is characterized by degeneration of the intervertebral discs and osteophytes formation. It is often asymptomatic but may cause radiating neck pain into back of head, shoulder, arm or may be the source of headache in posterior occipital region. In classical Unani literature cervical spondylosis is mentioned as neck pain and has been described as Waja ul Unuq type of waja ul Mafasil , derrangement of humours and accumulation of morbid humours are among its causes. Cervical Spondylosis is such a common and disabling condition preventing patients from certain physical activities and it is felt that it should be managed through multiple approaches that are pharmacological, non pharmacological and surgical . The use of NSAIDs and corticosteriods provide significant improvement in symptoms but their prolong use may induce side effects , similarly most of the patients avoid surgery due to complications associated with it. Unani scholars have successfully treated neck pain through various methods and claimed them effective but thie effectiveness needs scientific validation. Hence the trial entitled Clinical Study of Cervical Sponydlosis with Therapeutic evaluation and safety of Habb waja ul Mafasil in its management has been selected
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