| CTRI Number |
CTRI/2025/06/089381 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Heerbal Approach To Arthritis Unani Formulation Shows Promise In knee Pain Management |
|
Scientific Title of Study
|
Comparative Evaluation Of Efficacy Of The Unani Polyherbal Formulation And Habb Suranjan In Waja Al Mafasil(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 BiBi Akila |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College |
| Address |
OP No.5M, Department of PG-MOALAJAT, Govt. Unani Medical College,Arignar Anna Hospital Campus, Arumbakkam, Chennai
OP No.5M, Department of PG-MOALAJAT,Govt. Unani Medical College,Arignar Anna Hospital Campus, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9841761783 |
| Fax |
|
| Email |
akilabibi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mubasheera Begum |
| Designation |
Professor |
| Affiliation |
Government Unani Medical College |
| Address |
OP No.5M, Department of PG-MOALAJAT, Govt. Unani Medical College,Arignar Anna Hospital Campus, Arumbakkam, Chennai
OP No.5M, Department of PG-MOALAJAT, Govt. Unani Medical College,Arignar Anna Hospital Campus, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9841620486 |
| Fax |
|
| Email |
muskaan.m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mubasheera Begum |
| Designation |
Professor |
| Affiliation |
Government Unani Medical College |
| Address |
OP No.5M, Department of PG-MOALAJAT, Govt. Unani Medical College,Arignar Anna Hospital Campus, Arumbakkam, Chennai
OP No.5M, Department of PG-MOALAJAT, Govt. Unani Medical College,Arignar Anna Hospital Campus, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
09841620486 |
| Fax |
|
| Email |
muskaan.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| AAGHIM, Anna Hospital Campus, Arumbakkam, Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government Of Tamilnadu |
| Address |
Government Unani Medical College Arumbakkam,Chennai-600107 |
| Type of Sponsor |
Government medical college |
|
|
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 BiBi Akila |
Arignar Anna Government Hospital of Indian Medicine |
Arignar Anna Hospital, Department of Moalajat, Room No.5M, Arumbakkam, Chennai
Chennai
TAMIL NADU |
09841761783
akilabibi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Instituitional Ethics Committee(IEC) for Unani Medical Research for PG Scholars of M.D.(Unani) affiliated to The TN Dr. MGR Medical University, Chennai |
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 |
| Comparator Agent |
Habb Suranjan
Elwa/sibr (Aloe Barbadensis), Halela (Terminalia chebula), and
suranjan Shirin (Colchium autumnale) in equal proportion. |
Habb-e-Suranjan is a pharmacopeial preparation taken from the Anna Pharmacopeia pg
no.37(kharabadeen-E-jadeed). |
| Intervention |
Unani Polyherbal Formulation
Hulba (Trigonella Foenum-Graecum), Ajwain (Tachyspermum Ammi), Haloon
(Lepidium Sativum Linn), And Kalonji (Nigella Sativa). |
Equal Quantity Of All drugs Powdered.Route Of Administeration Oral Dosage 5gm BD For 45 Days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Radiological changes as per grades I to IV of the Kellgren and Lawrence Radiological scale.
Patients of OA Knee Joint as per ACR Criteria
The presence of knee pain with at least one of the following three items along
with osteophyte in knee X-ray can classify the knee OA in the patients
30 years and above
Morning stiffness less than 30 minutes
Crepitus on knee motion.
Willing to comply with the protocol
|
|
| ExclusionCriteria |
| Details |
Participants age below 30 years and above 65 years.
Intervention concerning History of any Trauma/Fractured joint/Surgical/Knee
replacement/intra articular injections.
Any unstable cardiovascular disease, chronic systemic illness, and any evidence of
malignancy.
Other types of osteoarthritis Rheumatoid arthritis, etc.
Pregnant and lactating women.
Mentally unstable patients. Participants who are currently participating in any other
clinical trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of the Unani test drug with the well-validated WOMAC CRD
PUNE and VAS scale. |
Baseline, 1st week ,2nd week, 4thweek , 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in QOL with WOMAC(Modified)CRD PUNE in OA patients from
baseline to 6 weeks. |
Baseline, 1st week ,2nd week, 4thweek , 6th week |
|
|
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)
|
30/06/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Waja al Mafasil Osteoarthritis is a
comprehensive term that is applied to a variety of joint pain. The term is
commonly employed for joint pain. It encompasses all kinds of joint pain such
as Niqris (gout) Waja ul Warik (ischial pain) Irq al nisa (sciatica)Waja ur Rakba
(Knee Osteoarthritis) etc.Osteoarthritis is a degenerative joint disease. It
produces pain, swelling, and stiffness, affecting a persons ability to move
freely. It affects the entire joint, including the tissues around it. It is
most common in the knees, hips, spine, and hands. Obesity, advanced age, and
prolonged, joint use are risk factors for this illness. Pain, stiffness, and
lack of movement are how they are clinically represented. It contributes to
chronic pain, disability, and reduced quality of life. The WHO estimated around
355 million people worldwide suffer from osteoarthritis, and by 2040, its
expected to influence even 25% of the population. In India, OA is the 2nd most
common problem and most frequently occurring joint disease with a prevalence of
22% to 39%. Conservative management for knee OA includes NSAIDs (Non-Steroidal Anti-inflammatory
drugs) Corticosteroid injections physiotherapy Acupuncture and Weight reduction
management, surgery to repair the joint, and lastly joint replacement. Despite
conventional treatment, OA is often progressive and frequently leads to chronic
pain and disability and develops side effects. It is the most common joint
disease worldwide, affecting an estimated 10% of men and 18% of women over 60
years of age. As per the humoral concept of Unani medicine, it may be caused by
Su-i-Mizaj Sada and Su I Mizaj Maddi (morbid temperament) due to abnormal
Akhlat (morbid humour) involvement. In the Unani system of medicine, the main
principles of treatment include Ilaj Bil
Taghdiya (Dietotherapy), Ilaj bil Tadbeer (Regimenal therapy), and Ilaj bil
Dawa (Pharmacotherapy). All the said principles are recommended for the
treatment of Waja-al Mafasil. Variations in the principles and management of
different types of Waja-al-Mafasil differ. Preventing morbidity and disability
is the primary objective of the treatment of patients with waja al mafasil. In
Ilaj Bil dawa(pharmacotherapy) several single drugs such as suranjan Shirin
(Colchicum autumnale), bozidan (pyrethrum indicum), zanjabeel (zingiber
officinalis) anisoon (Pimpinella anisum), etc and in compound majoon suranjan
and majoon ushba are us |