| CTRI Number |
CTRI/2025/06/089157 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Unani regimen in patients suffering from joint pain |
|
Scientific Title of Study
|
A Clinical Study to evaluate the efficacy of the Munzij Mushil therapy along with Coded Unani Drugs UNIM318 and UNIM319 and dry fomentation in patients of Primary Tahajjur-e-mafasil called as Osteo Arthritis Grade I and II. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahboob Us Salam |
| Designation |
Research officer |
| Affiliation |
Central Council for Research In Unani Medicine |
| Address |
Clinical Research section, OPD Hall Number 1, Room No.6 Central Research Institute of Unani Medicine, Kursi Road, Lucknow
Lucknow
UTTAR PRADESH
226021
India |
| Phone |
8521896528 |
| Fax |
|
| Email |
salammehboob@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahboob Us Salam |
| Designation |
Research officer |
| Affiliation |
Central Council for Research In Unani Medicine |
| Address |
Clinical Research Section,OPD Hall No.1, Room No.6,Central Research Institute of Unani Medicine, Kursi Road, Lucknow
Lucknow
UTTAR PRADESH
226021
India |
| Phone |
8521896528 |
| Fax |
|
| Email |
salammehboob@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mahboob Us Salam |
| Designation |
Research officer |
| Affiliation |
Central Council for Research In Unani Medicine |
| Address |
Clinical Research Section,OPD Hall No.1, Room No.6,Central Research Institute of Unani Medicine, Kursi Road Lucknow
Lucknow
UTTAR PRADESH
226021
India |
| Phone |
8521896528 |
| Fax |
|
| Email |
salammehboob@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine, Ministry of AYUSH, Govt.of India,
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058, India |
| 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 |
| Dr Mahboob Us Salam |
Central Research Institute of Unani Medicine |
Clinical Research Section, OPD Hall NO.1,Room No.6, Basaha, Kursi Road ,Lucknow, 226021
Lucknow
UTTAR PRADESH |
8521896528
salammehboob@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee - CRIUM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M199||Osteoarthritis, unspecified site, (2) ICD-10 Condition: M199||Osteoarthritis, unspecified site, (3) ICD-10 Condition: M199||Osteoarthritis, unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Munzij Mushil therapy along with Coded Unani Drugs UNIM318 and UNIM319 and dry fomentation |
The enrolled patient will be admitted in IPD for 21 day and will be administered with Munzij drugs in the form of decoction with 200ml orally once daily in the morning on empty stomach for 15days or till the Nuzj appears. After that Mushil drugs will be added in the decoction of Munzij and will be given to patients orally for 5 alternate days in the morning at a dose of 200ml while Tabreed with khamira Gauzaban 10g Luab e Behdana 3g Sheer e Unnab 5g will be given orally in the morning alternative to Mushil for 5 days.
After completing the Munzij Mushil and Tabreed the Unani coded drug UNIM 318 in the form of capsule will be given orally for 90 days at a dosage of 2 capsules of 500mg each with water thrice a day.
Patients will be advised to apply the Unani coded oil UNIM 319 on affected joints in the dosage of 5 to 10 ml once daily 90 days and do gentle massage for 5 minutes. Hot dry fomentation with infrared lamp will be done on affected joints for 21 days during the hospital stay
|
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
With or without overweight BMI 30
With clinical signs and symptoms pain swelling tenderness stiffness 30 minutes and creaking in knee joints if knees involved
4 Positive findings in Osteoarthritis Grade I and II by Radiology
5 ESR40 mm hr C reactive protein 10 mg l will be considered for inclusion in the study
6 Patient agrees to remain in study with assured co-operation in all respects till completion of the study
|
|
| ExclusionCriteria |
| Details |
1 R A systemic joint diseases or any other type of arthritis
2 Pregnancy lactating woman
3 Hypertension and other cardiovascular diseases
4 Diabetes and other metabolic disorders
5 Tuberculosis and other respiratory diseases
6 Gastrointestinal bypass surgery including irritable bowel syndrome
7 Renal hepatic impairment
8 History of presence of malignancy
9 History of alcohol and drug abuse
10 Epilepsy and other neurological disorders
11 Patient receiving treatment with experimental drugs within
a 30 days prior to the study
12 Intra articular treatment Such that Corticosteroid or hyaluronic acid or treatment with medicine for O A in previous 3 months such that Glucosamine sulphate Chondroitin sulphate Diacerine etc
13 Arhroscopy or any knee surgery in the previous 6 months
14 Treatment with anticoagulant or history of haemophilia
15 ESR 40mm hr and CRP level 10 mg L
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms such as joint pain, swelling, difficulty in movement. Improvement in biochemical indices such as S. uric acid and CRP. |
119 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No significant changes in hematological & biochemical indices such as CBC LFT & KFT ensuring safety of the regimen |
At baseline 30 days 60 days & 90 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 3 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A clinical study is planned to evaluate the efficacy and safety of the Munzij, Mushil and Tabreed therapy along with Coded Unani Drugs UNIM-318 and UNIM-319 and dry fomentation in patient of Tahajjur-e-Mafasil known as primary osteo-arthritis Grade I and II. The protocol of the study has been approved by the IEC of CRIM Lucknow. A total number of 60 patient will be recruited in the study and will receive the Unani regimen as mentioned above for 119 days. The efficacy will be assessed based on improvement in joint pain, swelling and difficulty in movement for which VAS score will be employed. The safety of the regimen will be assessed based on the changes in biochemical and hematological indices. The study will help establish relatively safe and effective Unani regimen for the treatment of osteo-arthritis. |