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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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. 
 
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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