| 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
|
|
|
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
|
|
|
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 worldThe 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 spondylosisThe 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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