| CTRI Number |
CTRI/2021/12/038829 [Registered on: 22/12/2021] Trial Registered Prospectively |
| Last Modified On: |
21/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of Unani research drug Qurs-e-Mafasil with allopathic drug Paracetamol in patients with Osteoarthritis |
|
Scientific Title of Study
|
A Single Blind, Randomized, parallel group study to compare efficacy and safety of
Unani formulation Qurs-e-
Mafasil with Paracetamol in
patients with Tahajjur al-Mafasil(Osteoarthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| TM/OA/QM/RCT/CCRUM/19-20,version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
Infrastructural support : 1 Central Research Institute of Unani Medicine (CRIUM), Lucknow Monetary Support: Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| 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 Najmus Sehar |
Central Research Institute of Unani Medicine (CRIUM), Lucknow |
Research OPD room (Tahajjur al-Mafasil) Vill. and Post Basaha, Kursi Road, Lucknow
Lucknow
UTTAR PRADESH |
7903422298
nsehar.ccrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Research Institute of Unani Medicine, Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Qurs-e- Mafasil |
Two tablets (500 mg each) twice a day orally to be taken with water after meals for 8 weeks |
| Comparator Agent |
Tablet Paracetamol |
One tablet (500 mg)twice a day orally to be taken with water after meals for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects fulfilling ACR clinical criteria for knee OA; andor
2. Subjects having grade II and III Osteoarthritisin knee radiography as perKellegrenLawrence criteria
3. Subjects presenting with/ without the following signs and symptoms:
Joint Pain
Early morning stiffness
Tenderness
Swelling
Reduced mobility |
|
| ExclusionCriteria |
| Details |
1. Subjects having Rheumatoid arthritis, Systemic joint disease or any other type of arthritis
2. Obese Subjects having BMI>30
3. Subjects with uncontrolled Hypertension, Diabetes Mellitus, Tuberculosis, Malignancy, Epilepsy and any other disease requiring long-term treatment
4. Known cases of Renal/ hepatic impairment
5. Patient receiving Intra-articular treatment (e.g., Corticosteroid or Hyaluronic acid) or treatment with medicine for O.A. in previous 3 months (e.g., Glucosamine sulphate, Chondroitin sulphate, Diacerine piascledine)
6. Subjects undergone Arthroscopy or any Knee surgery during last 6 months
7. Pregnancy & lactation |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Improvement in clinical sign and symptoms
• Radiological evolution assessed by Joint space narrowing
• Evaluation of pain by visual analog scale (VAS pain)
• Western Ontario MacMaster University Osteoarthritis Index (WOMAC) |
8weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haematological and biochemical assessments for safety
|
8weeks |
|
|
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)
|
31/12/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single blind
randomized parallel group trial in patients with Tahajjur
al-Mafasil(Osteoarthritis). Patients will be enrolled if they
satisfy inclusion and exclusion criteria. The patients enrolled in the
study will receive the medicine Qurs-e- Mafasil or Tablet Paracetamol as allocated by randomization method. The
total duration of treatment will be 8 weeks and the follow-up for all clinical
parameters will be conducted every two weeks. The laboratory tests will be
conducted at all follow ups. | S. No. | Ingredients | Scientific names | Quantity | | 1. | Zanjabeel | Zingiber officinale R. | 1 part | | 2. | Suranjan | Colchicum luteum B. | 2 parts | | 3. | FilfilSiyah | Piper nigrum L. | 1 part | | 4. | Asgand | Withaniasomnifera D. | 1 part |
|