| CTRI Number |
CTRI/2024/07/070116 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
28/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Unani formulations in knee ostioarthritis |
|
Scientific Title of Study
|
Comparative clinical study on the efficacy of Habb-e-Mafasil with Roghan-e-Banafsha and Habb-e-Gul-e-Aakh with Roghan-e-Haft Barg in Wajaʹur Rukbah (Knee Osteoarthritis)- A Randomized Clinical trial |
| 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 Mohd Razaullah |
| Designation |
P.G Scholar |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat National Institute of Unani Medicine ,Kottigepalya,Magadi Main Road Bengaluru Karnataka
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
9818208491 |
| Fax |
|
| Email |
razaullahrazee@gmsil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohd Riyazuddin |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat National Institute of Unani Medicine ,Kottigepalya,Magadi Main Road Bengaluru Karnataka
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
8010392768 |
| Fax |
|
| Email |
Shaikh.riyaz368@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohd Riyazuddin |
| Designation |
Assistant professor |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Moalajat National Institute of Unani Medicine ,Kottigepalya,Magadi Main Road Bengaluru Karnataka
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
8010392768 |
| Fax |
|
| Email |
Shaikh.riyaz368@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Bengaluru |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine, Bengaluru |
| Address |
National Institute of Unani Medicine,Kottigepalya Magadi Main Road Bengaluru 560091 |
| 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 Mohd Razaullah |
National Institute of Unani Medicine |
OPD and IPD Department of moalajat, national institute of unani medicine
Bangalore
KARNATAKA |
9818208491
razaullahrazee@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the institutional ethics committee (IEC) for biomedical research |
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 |
Habb-e- Gul-e- Aakh
Roghan-e- Haft Barg |
Habb-e- Gul-e- Aakh
Dose: 2 gm per day in two divided doses (2 pills of 500 mg twice a day after meals)
Roghan-e- Haft Barg
Dose: 10-15 ml per day
|
| Intervention |
Habb-e- Mafasil,Roghan-e- Banafsha |
Habb-e- Mafasil: 3 gm per day in two divided doses (2 pills of 750mg twice a day after meals)
Roghan-e- Banafsha:10-15 ml per day |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of OA Knee Joint as per ACR Criteria16 (clinical, radiographical and laboratory).
2.Subjects of all genders aged 45-70 years.
3.Grade I and II of Kellgren Lawrence grading scale17
|
|
| ExclusionCriteria |
| Details |
1.Subjects who experience a rapid worsening of knee symptoms, have a hot swollen knee, have a previous knee replacement on the affected knee, have a history of significant trauma to the affected knee, have a joint injection or arthroscopy in the past 6 months, or have any major surgery in the last year.
2.Subjects currently taking, or in the past 3 months were taking, pain-relieving medications (e.g., nonsteroidal anti-inflammatory drugs, analgesics, and corticosteroids).
3.Subjects diagnosed with gout or pseudo gout within the last 3 months, have a history of gout in the knee joint, diagnosed with other inflammatory arthritis (e.g., rheumatoid arthritis, septic arthritis), and malignancy, diagnosed with a complex pain disorder or severe immobility (e.g., complex regional pain syndrome, severe back pain, multiple sclerosis, muscular dystrophy, Parkinson’s disease, or hemiplegia).
4.Participants with a recent diagnosis of, and/or currently suffering from uncontrolled medical conditions including but not limited to diabetes (RBS≥180mg/dl), hypertension (≥140/90mmHg), cardiovascular disease gall bladder disease/gallstones/biliary disease, endocrine disease, or malignancies.
5.Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC –Modified CRD Pune version) |
0th day, 7th day, 14th day, 21th day, and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Reduction in Pain intensity as per WOMAC (Modified CRD Pune version) pain scale
2)Reduction in stiffness as per WOMAC (Modified CRD Pune version) stiffness scale
3)Reduction in Restrictions of movements as per WOMAC (Modified CRD Pune version) physical activity scale
|
0th day, 7th day, 14th day, 21th day, & 28th day |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
10/07/2024 |
| 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
|
Objective of the study: The objective of the study is to compare the efficacy of Habb-e-Mafasil and Roghan-e-Banafsha with Habb-e-Gul-e-Aakh and Roghan-e-Haft Barg in Wajaʹur Rukbah (Knee osteoarthritis). Study design: Single blind, Randomized Comparative Clinical Trial Sample size: 44 subjects, 22 in each group Intervention: Test Group: Habb-e- Mafasil: Dose: 3 gm per day in two divided doses (2 pills of 750mg twice a day after meals)
Route of administration: Oral Roghan-e- Banafsha Dose: 10-15 ml per day Route of administration: Local Control Group: Habb-e- Gul-e- Aakh Dose: 2 gm per day in two divided doses (2 pills of 500 mg twice a day after meals) Route of administration: Oral Roghan-e- Haft Barg Dose: 10-15 ml per day Primary outcome: Reduction in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC –Modified CRD Pune version) Secondary outcome: 1) Reduction in Pain intensity as per WOMAC (Modified CRD Pune version) pain scale 2) Reduction in stiffness as per WOMAC (Modified CRD Pune version) stiffness scale 3) Reduction in Restrictions of movements as per WOMAC (Modified CRD Pune version) physical activity scale
|