| CTRI Number |
CTRI/2023/03/050729 [Registered on: 15/03/2023] Trial Registered Prospectively |
| Last Modified On: |
14/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study to evaluate the efficacy and safety of a unani formulation in the management of Waja‘ al-MafÄá¹£il (Osteoarthritis) |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a Unani Formulation in the Management of Waja‘ al-MafÄá¹£il (Osteoarthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACT/WM/OA/UF/NRIUM/2020-21 Version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Haris Afzal |
| Designation |
M.D. Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders. |
| Address |
Dept. of Moalajat, National Research Institute of Unani Medicine for Skin Disorders.
AGs Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad- 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9794513760 |
| Fax |
|
| Email |
harisafzalaazmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor & HOD |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
Dept. of Moalajat, National Research Institute of Unani Medicine for Skin Disorders.
AGs Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad- 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
ccrumhqrsnd58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Haris Afzal |
| Designation |
M.D. Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders. |
| Address |
Dept. of Moalajat, National Research Institute of Unani Medicine for Skin Disorders.
AGs Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad- 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9794513760 |
| Fax |
|
| Email |
harisafzalaazmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders. |
| Address |
AGs Colony Road, Opp. ESI Hospital, Erragadda, Hyderabad- 500038 |
| 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 Haris Afzal |
National Research Institute of Unani Medicine for Skin Disorders. |
OPD & IPD of Dept. of
Moalajat, National
Research Institute of
Unani Medicine for Skin
Disorders. AGs Colony
Road, Opp. ESI
Hospital, Erragadda,
Hyderabad- 500038
Hyderabad
TELANGANA |
9794513760
harisafzalaazmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NRIUMSD, Hyderabad. |
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 |
| Comparator Agent |
Celecoxib |
Dosage Form: Capsule,
Route of Administration: Oral,
Dosage: 1 Capsule (100 mg) twice a day with water after meals.
Total Duration of Comparator: 6 Weeks (42 Days) |
| Intervention |
Unani Formulation |
Dosage Form: Majun (Electuary),
Dosage: 10 g/day (5 gm twice daily with water after meals),
Route of Administration: Oral,
Composition: 1. Suranjan Shirin (Merendra persica) 35g, 2. Zanjabeel (Zingiber officinale Rosc.) 7g, 3. Hina (Lawsonia inermis Linn.) 7g, 4. Harmal (Peganum harmala Linn.) 7g, 5. Mirch Siyah (Piper nigrum Linn.) 7g, 6. Bekh Kibr (Capparis spinosa Linn.) 7g, 7. Asal (Honey) Q.S.
Total Duration of Intervention: 6 Weeks (42 Days) |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of any gender aged 50-65 years
2. Clinical and Radiographic Knee Osteoarthritis as per the following ACR criteria:
(a) Knee Pain
(b) Osteophytes on Knee Radiograph, and
(c) At least 1 of the following 3 criteria:
i. Age ≥50 years
ii. Morning Stiffness lasting ≤30 minutes
iii. Crepitus on Active Knee Motion
3. Knee OA of Kellgren-Lawrence Grade I to III
4. Body Mass Index (BMI): <40 Kg/m2 |
|
| ExclusionCriteria |
| Details |
1. Age less than 50 years and more than 65 years
2. Knee OA of Kellgren-Lawrence grade IV
3. BMI more or equal to 40
4. Patients with Knee Joint Effusion
5. Secondary OA, Inflammatory joint diseases (e.g., RA, ankylosing spondylitis, psoriatic arthritis, gout), or any other type of arthritis
6. Patients on long-term steroid treatment
7. History of having received intra-articular knee injection (corticosteroids or hyaluronan), or any investigational drug in the previous one month
8. Any significant systemic diseases (hepatic, renal gastrointestinal, cardiovascular, neurologic or psychiatric disorder) and Diabetes Mellitus
9. History of Peptic Ulcer Disease & Bleeding Disorders
10. Known hypersensitivity to study drug or any of its ingredients
11. Pregnant and lactating women
12. History of addiction (alcohol, drugs)
13. Patients considered not eligible in the Investigator’s opinion
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The decrease in severity of pain, stiffness and limitation of function of affected knee will be assessed by WOMAC OA Index.
2. The decrease in the severity of pain in affected knee will be assessed by 0-100 mm Visual Analog Scale (VAS)
3. Joint tenderness (pain on palpation) will be graded on a 4-Point Likert Scale (0-3) based on the patient’s response to palpation over the affected joint.
4. Patient’s Global Assessment of Response to Therapy (PGA) on a 5- point Likert Scale (0-4)
5. Investigator’s Global Assessment of Response to Therapy (IGA) on a 5-point Likert Scale (0-4)
6. 50-Foot Walk Test (50-FWT) will also be used to study physical performance. |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Systemic safety assessment |
6 Weeks |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2023 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis (OA) is the most common chronic joint disease with a prevalence of 22-39% in India. NSAIDs (Non-steroidal Anti-inflammatory Drugs) are widely used in the symptomatic management of OA. But, NSAIDs cannot be used for a long period because they have so many adverse effects such as bleeding, gastrointestinal ulcer, etc. There are so many Unani formulations, which have been used in the treatment of Waja‘al-MafÄá¹£il (Osteoarthritis) by Unani Physicians since ages, one of them is this Classical Unani Formulation containing several herbs in the form of Majun to be made with Honey, which has been selected for a clinical study to evaluate its safety and efficacy on modern scientific parameters in the Management of Waja‘ al-MafÄá¹£il (Osteoarthritis). Participants fulfilling the inclusion and exclusion criteria will receive either test or control drug as per randomization, in test drug participants will receive classical unani formulation in the form of Majun (electuary) 5gm to be taken orally twice a day after meals. In control drug participants will be given 1 Celecoxib capsule (100mg) to be taken orally twice a day after meals. various parameters like WOMAC OA Index, Visual Analogue Scale, Likert Scale, 50-Foot Walk Test will be used to evaluate the efficacy and various laboratory investigations will be done to evaluate the safety of the test drug. Duration of the study is 6 weeks. Statistical Analysis: Chi-square test and “student-t test†will be used to evaluate the significance of results. For intra-group comparison, ‘paired t-test’ and for inter-group comparison ‘unpaired t-test’ will be applied. The p-value of <0.05 will be considered as the level of statistical significance. |