| CTRI Number |
CTRI/2025/07/090665 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
10/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study To Evaluate Efficacy Of Unani Formulation In The Management Of Cervical Spondylosis (Waja-al-Unuq) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of Unani Formulation in the Management of Waja-al-Unuq (Cervical Spondylosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RUKHSAR ASLAM |
| Designation |
PG Scholar |
| Affiliation |
State Takmeel ut Tib College And Hospital |
| Address |
Department Of Moalajat State Takmeel ut Tib College And Hospital Near Ramabai Railly Sthal Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
7985538450 |
| Fax |
|
| Email |
001draslam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Zubair |
| Designation |
Lecturer |
| Affiliation |
State Takmeel ut Tib College And Hospital |
| Address |
Department Of Moalajat State Takmeel ut Tib College And Hospital Near Ramabai Railly Sthal Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8318016554 |
| Fax |
|
| Email |
mzaligmd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulnaz Fatima |
| Designation |
Lecturer |
| Affiliation |
State Unani Medical College Prayagraj |
| Address |
Department Of Moalajat State Unani Medical College Prayagraj
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
7503668599 |
| Fax |
|
| Email |
gulfatima123@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel ut Tib College And Hospital Near Ramabai Railly Sthal 226025 Lucknow UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
State Takmeel ut Tib College And Hospital |
| Address |
Near Ramabai Railly Sthal Lucknow |
| 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 RUKHSAR ASLAM |
State Takmeel ut Tib College and Hospital |
Department of Moalajat, Near Ramabai Railly Sthal, Bijnor Road 226025
Lucknow
UTTAR PRADESH |
7985538450
001draslam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Takmeel ut Tib College And Hospital Lucknow |
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 |
1. Unani poly herbal formulation
2. Roghan-e-zanjabeel |
1. Unani poly herbal formulation:
Dose and Dosage: 04 gram of Safuf (Powder) will be prescribed daily twice a day, after meal with normal water.
Route of administration: Oral
Composition of Unani poly herbal formulation:
Suranjan sheerin (colchicum autumnale)
Zanjabeel (zingbiber officinalis)
Zeera kirmani (carum carvi linn.)
Sibr (aloe barbadensis)
Duration of protocol therapy: 60 Days
2. Roghan-e-Zanjabeel
Dose and Dosage: 5ml of Roghan (oil) will be applied locally over cervical region with gentle massage daily twice a day.
Composition of Roghan-e-Zanjabeel :
Til ka tail ( sesamum indicum)
Ginger water ( zingiber officinalis)
Duration of protocol therapy:60 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically stable patient having complain of
Cervical spondylosis (neck pain tenderness paraesthesia or numbness and restricted movement of neck).
2. Radiologically diagnosed patients of Waja-al-Unuq (C.S)
Using Kettlers Grading Scale based on cervical disc degeneration (with the concern of radiologist).
3. Patients belonging to 25 to 60 years of age in both sexes
4. Patients able to participate in the study and ready to follow the instructions and sign the consent form |
|
| ExclusionCriteria |
| Details |
1. Pregnancy, lactating mothers and women using OCPs drug.
2. Spinal tumour or cancer.
3. Any post healed cervical fracture, congenital spinal deformity.
4. Patients having systemic as well as metabolic diseases like liver, kidney, Cardiac, pulmonary diseases, Epilepsy, Diabetes and HTN.
5. Patient taking corticosteroids.
6. Cervical rib syndrome.
7. Raw skin lesion on neck.
8. Patients unsure about attending treatment schedule regularly.
9. Patients with the history of trauma and accidents.
10. Patients suffering from immunological diseases like HIV, hepatitis and malignancy.
11. Grade 3 scale of Kettler’s Grading System. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in Patient’s Global Assessment on VAS
2.Improvement in Clinical symptoms on Likert Scale |
Clinical assessment will be done at Baseline, 2nd, 4th, 6th and 8th weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in Kettlers Grading System. |
Clinical assessment will be done at Baseline & 8th weeks. |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
21/07/2025 |
| 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="6"
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 dissertation titled “A Clinical Study to Evaluate the Efficacy and Safety of Unani Formulation in the Management of Waja-al-Unuq (Cervical Spondylosis)” by Dr. Rukhsar Aslam focuses on assessing a traditional Unani treatment for cervical spondylosis a degenerative condition of the cervical spine. The study aims to scientifically validate the effectiveness and safety of a specific Unani polyherbal formulation, both orally (powder form) and topically (Roghan-e-Zanjabeel).
Key Components:
Background: Cervical spondylosis is a common spinal issue causing neck pain, stiffness, and neurological symptoms. Unani medicine refers to it as Waja-al-Unuq, part of the broader category Waja-al-Mafasil (joint pain), attributing the cause to abnormal phlegm accumulation.
Objective: To evaluate the efficacy and safety of a Unani formulation made of Suranjan sheerin, Zanjabeel, Zeera kirmani, Sibr (oral) and Roghan-e-Zanjabeel (local application).
Methodology:
Pre-post single-arm clinical trial.
35 patients aged 25–60 with radiologically diagnosed cervical spondylosis.
Treatment duration: 60 days.
Assessment based on clinical symptoms Kettler’s Grading System VAS (Visual Analogue Scale) and safety lab tests (LFT KFT RBS).
Ethical Clearance: Sought and approved by the institutional ethics committee.
Conclusion: This study seeks to provide a safer affordable alternative to conventional therapies for cervical spondylosis using traditional Unani methods contributing to evidence-based validation of classical treatments. |