| CTRI Number |
CTRI/2025/03/082302 [Registered on: 13/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [UNANI FORMULATION] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on Knee Osteoarthritis. |
|
Scientific Title of Study
|
A Randomized, Parallel group, Open label, Active controlled clinical study to evaluate the safety and efficacy of a Unani Formulation in the management of Waja al mafasil Rukba (Knee Osteoarthritis) |
| 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 Momin Sarwat Iram |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
| Address |
National Research
Institute Of Unani Medicine For Skin Disorders,Department Of Moalajat, A.G
Colony Road, Opposite Esi Hospital,Erragadda,Hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
8788166582 |
| Fax |
|
| Email |
mominsarwatiram@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qamaruddin |
| Designation |
Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
National Research
Institute Of Unani Medicine For Skin Disorders,Department Of Moalajat, A.G
Colony Road, Opposite Esi Hospital,Erragadda,Hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
Qamaruddindr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Momin Sarwat Iram Momin Masood Arif |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
National Research
Institute Of Unani Medicine For Skin Disorders,Department Of Moalajat, A.G
Colony Road, Opposite Esi Hospital,Erragadda,Hyderabad.
Hyderabad
TELANGANA
500038
India |
| Phone |
8788166582 |
| Fax |
|
| Email |
mominsarwatiram@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research
Institute Of Unani Medicine For Skin Disorders,Department Of Moalajat, A.G
Colony Road, Opposite Esi Hospital,Erragadda,Hyderabad.
500038
India |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders |
| Address |
A.G
Colony Road, Opposite Esi Hospital,Erragadda,Hyderabad.
500038
|
| 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 Momin Sarwat Iram |
National Research Institute Of Unani Medicine For Skin Disorders |
OPD and IPD, National Research
Institute Of Unani Medicine For Skin Disorders,Department Of Moalajat, A.G
Colony Road, Opposite Esi Hospital,Erragadda,Hyderabad.
Hyderabad
TELANGANA |
08788166582
mominsarwatiram@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: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Unani Formulation(pills) |
Unani Formulation Containing Sibr zard(Aloe barbadensis),Safoof Amla(Emblica officinalis), Safoof Haleela(Terminalia chebula), Gogul(Commiphora mukul) will be used 500mg orally In the form of pills twice a Day.
|
| Comparator Agent |
Paracetamol |
Dosage form:Tablet
Route of administration:Oral |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Participants of any gender(male and female) in the age group of (50-70)years. Participant having Knee Pain Osteophytes on Knee Radiograph, Morning Stiffness lasting upto 30 minutes and Crepitus on Active Knee Motion.
Body Mass Index below 40 kilogram per meter square.
Participants willing to sign the ICF and comply with the protocol. |
|
| ExclusionCriteria |
| Details |
The following participants will be excluded from the study:
Participants aged less than (50 years) and more than( 70 years)
Systemic and metabolic illnesses like IHD, TB, and Malignancy.
Patients with Knee pain other than osteoarthritis.
Patients with Osteoarthritis affecting joints other than the knee joint.
History of Knee injury, surgery, steroid injection in knee joints
Pregnancy and lactation
Patients under treatment of steroids
• Morbid Obesity BMI more than 40 |
|
|
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 |
| Reduction in the total Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC–Modified CRD Pune version) |
At baseline 7th,14th,21st and 28th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Pain intensity as per WOMAC (Modified CRD Pune version) pain scale
• Reduction in stiffness as per WOMAC (Modified CRD Pune version) stiffness scale
• Reduction in Restrictions of movements as per WOMAC (Modified CRD Pune version)
physical activity scale |
At baseline and 28th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
08/05/2025 |
| 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
|
Osteoarthritis (Waja al mafasil) is by far the most common form of arthritis and is a major cause of pain and disability in older people. The prevalence of osteoarthritis rises strikingly with age, being uncommon in adults aged below 40 and highly prevalent in those aged more than 60.The available treatment in modern medicine, including corticosteroids, and knee replacement surgery have their limitations and adverse effects. In Unani medicine, various single and compound drugs are effectively used in the treatment of, Waja al mafasil but these drugs need to be evaluated on scientific parameters. Keeping this in view, the present clinical study has been designed to evaluate the safety and efficacy of an Unani formulation in the Management of Waja al mafasi; Rukba (Knee Osteoarthritis). |