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CTRI Number  CTRI/2026/03/106049 [Registered on: 12/03/2026] Trial Registered Prospectively
Last Modified On: 11/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) [Therapeutic ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effects of unani formulation in cervical pain 
Scientific Title of Study   Clinical study to evaluate the therapeutic effects of Safuf e Chobchini in the management of Waja al Unaq Cervical Spondylosis An open label block randomized standard control study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Zaffar Hussain 
Designation  Professor  
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  7006021996  
Fax    
Email  hussainzaffar6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Zaffar Hussain 
Designation  Professor  
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir


JAMMU & KASHMIR
190006
India 
Phone  7006021996  
Fax    
Email  hussainzaffar6@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Farhat Rashid  
Designation  PG Scholar  
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  6005256090  
Fax    
Email  drfarhatnaseem135@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine CCRUM, New Delhi, 110058 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRIUM 
Address  Regional Research Institute of Unani Medicine RRIUM University of Kashmir, Srinagar, Jammu and Kashmir, 190006  
Type of Sponsor  Research institution and hospital 
 
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 
Dr Zaffar Hussain   Regional Research Institute of Unani Medicine RRIUM   Moalajat OPD-1 Ground Floor Department of Moalajat RRIUM Naseem Bagh Campus University of Kashmir Hazratbal Srinagar Jammu and Kashmir
Srinagar
JAMMU & KASHMIR 
7006021996

hussainzaffar6@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: M472||Other spondylosis with radiculopathy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Safuf   It is a classical unani formulation( safuf chobchini) taken from National Formulation of Unani Medicine.The formulation comprises of Chobchini( Smilax chinensis(F.T Wang) P.Li & C.X.Fu ), Sana maki(Cassia angustifolia L),Ushba magribi( Smilax officinalis Kunth),Bisfayej(Polypodium Vulgare L), Suranjan shireen(Colchicum autumnate L),Aftimoon(Cuseuta reflexa Roxb.),Gul-e-Surkh(Rosa damascena Mill),Sandal Safaid(Santalum album L.).The formulation will be given 10 grams ( 5 grams twice a day ) after meals(breakfast and dinner) with water orally for 45 days  
Comparator Agent  Tablet   Tab Pregabalin 75 mg once a day half an hour after dinner for 45 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Patients between 18 to 65 years of age.
2.Patient irrespective of gender.
3.Clinically and radiologically diagnosed patients of Cervical spondylosis.
4.Patients who have agreed to sign the informed consent form and are willing to follow up as per the study protocol.

 
 
ExclusionCriteria 
Details  1.History of cervical trauma or injury.
2.Known case of uncontrolled Diabetes, Hypertension, impaired Renal and Hepatic functions.
3.Known case of cervical myelopathies.
4.Pregnant and lactating women.
5.Patient who refuse to give written consent for the study and unwillingness to come for regular follow up as described in the study plan.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change from baseline to 46 day in the X-Ray cervical spine
change from baseline to 46 day in Visual Analog Scale (VAS)

 
45 Days
 
 
Secondary Outcome  
Outcome  TimePoints 
Northwick Park neck pain questionnaire
Spurling sign
 
0 Day, 15th Day, 30th Day and 46th Day 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   01/04/2026 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The term Cervical spondylosis describes chronic degenerative lesions of single or multiple intervertebral discs with formation of osteophytes in related vertebral bodies. Cervical spondylosis is a leading cause of musculoskeletal disability in humans.

Most people with spondylotic changes of the cervical spine on radiographic imaging remain asymptomatic with 25% of individuals under the age of 40, 50% of individual over the age of 40, and 85% of individuals over the age of 60 showing some evidence of degenerative changes. The most frequently affected levels are C6-C7 followed by C5-C6. Symptomatic Cervical spondylosis most commonly present as neck pain.

In the general population, the point prevalence of neck pain ranges from 0.4% to 41.5%, the 1- year incidence ranges from 4.8% to 79.5%, and lifetime prevalence may be as high as 86.8%.According to the Global Burden of Disease 2019, neck pain ranked second only to back pain as a cause of total years lived with disability (YLD) and the fourth leading cause of disability -adjusted life years (DALYs). In general neck pain rankings were also higher in developed regions of the world

The international incidence of Cervical spondylosis is 2.5 cases per 1000 population. While in India, incidence is 3.5 cases per 1000 population. It is determined by the age of 70 approximately 100 percent of males, 96 percent of females will have some degree of Cervical spondylosis

The primary risk factor and contributor or the incidence of Cervical spondylosis is age-related degeneration of the intervertebral disc and cervical spinal elements. Degenerative changes in surrounding structures, including the uncovertebral joints, facet joints, posterior longitudinal ligament (PLL), and ligamentum flavum all combine to cause narrowing of the spinal vasculature, and nerve roots can be compressed, resulting in the three clinical symptoms in which Cervical spondylosis presents: axial neck pain, Cervical myelopathy and Cervical radiculopathy.

As for as the Unani  system is concerned, the term Waja al Unaq is not mentioned at all in any classic text, but most of the eminent physicians used the term Waja al Mafasil to represent all types of joint pain, and also named them accordingly like Niqris (Gout), Waja al-Warik (ischail pain), Irq al-Nasa (Sciatica), Waja al-Rakaba (knee pain) etc. Similarly, when Waja al-Mafasil occurs in Fiqrate Unaq and causes neck pain , it is known as Waja al Unaq (Cervical spondylosis), because here  Waja stands for Pain and Unaq stands for neck. So cervical spondylosis is also described as Waja al- Unaq  a type of Waja al-Mafasil, and treated as per the line of treatment of Waja al Mafasil as described in Unani text.

Presently there is no definite cure for Cervical spondylosis nor are there any pharmacological agents available that definitely affect the underlying pathological process. In Allopathic system of medicine the disease is usually treated by using NSAIDs, corticosteroids, antidepressants, cervical epidural steroid injection, surgery and certain physiotherapy regimens like TENS, tractions, and cervical collars etc. Though the use of these drugs provide significant improvement in symptoms of Cervical spondylosis on short term basis, but their prolonged use may induce side effects. However, the potential for serious side effects such as gastrointestinal bleeding and ulceration, exacerbation of hypertension and fluid retention; concerns about their renal and cardiovascular safety particularly in older individuals with co-morbidities limit their use. While in severe cases of Cervical spondylosis surgery is done which is too costly with unusual eventualities.

Therefore, search for safe and effective herbal formulation is neecd of an hour.To ascertain the effectiveness of Safuf-i- Chobchini , the current study named  Clinical study to evaluate the therapeutic effects of Safuf e Chobchini in the management of Waja al Unaq (Cervical Spondylosis): An open label, block randomized, standard control study  has been designed

 
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