| CTRI Number |
CTRI/2021/03/032178 [Registered on: 22/03/2021] Trial Registered Prospectively |
| Last Modified On: |
18/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of knee osteoarthritis with evaluation of safety and efficacy of Bozidan in its management. |
|
Scientific Title of Study
|
Clinical study of primary knee osteoarthritis ( waja ur Rukba) with therapeutic evaluation and safety of Bozidan (Pyrethrum indicum) in its management. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mir Idrees Hanief |
| Designation |
PG scholar |
| Affiliation |
Regional Research Institute of Unani Medicine Srinagar |
| Address |
Department of moalajat, RRIUM Srinagar, university of Kashmir naseembagh campus.
Department of moalajat OPD-2 Ground floor, RRIUM Srinagar university of Kashmir naseembagh campus
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7006929405 |
| Fax |
|
| Email |
dr.idreeshanief123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr shameem ahmad rather |
| Designation |
Reader department of moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine Srinagar |
| Address |
Department of moalajat OPD-1 ground floor RRIUM naseembagh campus University of Kashmir hazratbal Srinagar
Department of moalajat RRIUM naseembagh campus University of Kashmir hazratbal Srinagar
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
Shameem.rather.sr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr shameem ahmad rather |
| Designation |
Reader department of moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine Srinagar |
| Address |
Department of moalajat OPD-1 ground floor RRIUM naseembagh campus University of Kashmir hazratbal Srinagar
Department of moalajat RRIUM naseembagh campus University of Kashmir hazratbal Srinagar
Baramula
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
Shameem.rather.sr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central council for research in Unani medicine (CCRUM), New dehli |
|
|
Primary Sponsor
|
| Name |
Central council for research in Unani medicine New dehli |
| Address |
Regional Research Institute of Unani Medicine (RRIUM) university of Kashmir, Srinagar,CCRUM,New Delhi. |
| 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 |
| Mir Idrees Hanief |
Regional Research Institute of Unani Medicine, Srinagar |
Moalajat OPD-2 Ground floor Department of moalajat RRIUM naseembagh campus University of Kashmir hazratbal Srinagar
Srinagar
JAMMU & KASHMIR |
7006929405
dr.idreeshanief123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, RRIUM, Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bozidan( pyrethrum indicum) |
Powder of the root of bozidan(pyrethrum indicum)5 grams will be given once daily for 45 days half an hour after breakfast with lukewarm water |
| Comparator Agent |
Glucosamine sulphate |
glucosamine sulphate 1500 milligrams will be given once daily for 45 days half an hour after breakfast with lukewarm water once a day. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and radiologically diagnosed patients.
Kellgren and Lawrence grade 1,2 knee osteoarthritis.
Patients who agree to sign the informed consent.
|
|
| ExclusionCriteria |
| Details |
Kellgren and Lawrence grade 3, 4 knee osteoarthritis.
pregnant and lactating women.
BMI greater than 35kg per meter square.
History of recent knee infection.
Previous knee surgery.
patients with rheumatoid arthritis.
patients with history of systemic disease like diabetes, cardiovascular,hypertension,impaired renal or hepatic function.
patients who refuse to give the written consent. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of primary knee osteoarthritis. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| heamatological and biochemical assessment for safety |
45 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 2 |
|
Date of First Enrollment (India)
|
27/03/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Osteoarthritis is the most common form of arthritis and by far the most common joint disorder and a leading cause of disability world wide. The two cardinal features of osteoarthritis are joint space narrowing and osteophytes. Osteoarthritis is defined as painful degenerative process involving progressive detrioration of all joint surface and remodelling of subchondral bone that is not primarily inflammatory.Osteoarthritis is a disorder of diarthrodial (synovial joints) charecterised clinically by pain, tenderness, limitation of movements, crepitus, ocassionally effusion and variable degrees of local inflammation but without systemic effects, osteoarthritis is classified as primary (idiopathic) and secondary.Primary osteoarthritis is seen in weight bearing joints and is more common in obese patients older than 50 years.Progression of primary osteoarthritis is slow and prognosis is better. Secondary osteoarthritis is monoarticular in which the reaction of a joint to some condition has produced incongruity in its surfaces because of mechanical derrangements. Waja al mafasil (Osteoarthritis) is also known as ghatya or hadaar. Waja al mafasil is an arabic term which is a combination of two words ’Waja’ which stands for pain and ’mafasil’ which stands for joints , thus waja al mafasil literally means joint pain and is defined as the pain which occurs in joints not associated with a particularpart but the pain which occurs in knee, it is known as osteoarthritis knee.. Waja al mafasil is characterised by pain, swelling and redness with crepitus. This disease is mostly present in those individuals who have abnormally high quantity of humours, which then reach to joints. This disease usually occurs due to abnormally high levels of phlegm (balgham), which get mixed with yellow bile (safra) and then with blood (dam) and with the excess of these humours waja-al-mafasil is caused. Ibn sena considered waja-al-mafasil ,niqris(gout) and irq al nisa (sciatica) as a disease of same genus.The charecteristic feature of waja al mafasil is that neither it ripens nor puss is formed in it.
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