| CTRI Number |
CTRI/2025/03/083749 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Medicated steam therapy in Knee osteoarthritis |
|
Scientific Title of Study
|
A Randomized controlled pilot clinical study to evaluate the efficacy of Inkibab (medicated steam therapy) in the treatment of 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 |
Uzma Abid |
| Designation |
PI (BUMS Final Prof Student) |
| Affiliation |
Jamia Hamdard |
| Address |
Room No. 21, Ilaj bit Tadbeer Unit, Majeedia Unani Hospital, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9871085170 |
| Fax |
|
| Email |
logon2uzma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Uzma Abid |
| Designation |
PI (BUMS Final Prof Student) |
| Affiliation |
Jamia Hamdard |
| Address |
Room No. 21, Ilaj bit Tadbeer Unit, Majeedia Unani Hospital, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9871085170 |
| Fax |
|
| Email |
logon2uzma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadia Nikhat |
| Designation |
Assistant Professor |
| Affiliation |
Jamia Hamdard |
| Address |
Dept. of Ilaj bit Tadbeer, School of Unani Medical Education and Research,Jamia Hamdard, New Delhi.
South
DELHI
110062
India |
| Phone |
9990098725 |
| Fax |
|
| Email |
sadianikhat@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - 110058 (India) |
| 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 |
| Uzma Abid |
Majeedia Unani Hospital |
Room No. 21, Ilaj bit Tadbeer Unit, Majeedia Unani Hospital, Jamia Hamdard, New Delhi-110062
South
DELHI |
9871085170
logon2uzma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
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 |
Inkibab (steam therapy) with Plain water |
Inkibab (steam therapy) with plain water on the affected knee joint daily for 10 days (10 minutes in one sitting) |
| Intervention |
Inkibab (Steam Therapy) with Unani medicines |
Inkibab (steam therapy) with decoction of Matricaria chamomilla L, Trigonella glabra subsp. uncata, and (Butea monosperma (Lam.) Kuntze) on the affected knee joint daily for 10 days (10 minutes in one sitting). |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Knee OA in age groups of 30 to 60 years
Subjective pain intensity of 20 or more at baseline on Visual Analogue Scale (VAS).
Clinically stable patients
Patients of all genders
Patients willing to sign the informed consent form and participate in the trial voluntarily |
|
| ExclusionCriteria |
| Details |
Diabetes mellitus Type-1 and uncontrolled Type-2
Clinically unstable patients.
Patients suffering from any acute or chronic disorder in which vitals are beyond normal values, or there are clinical signs of electrolyte and metabolic disturbances
Pregnant and lactating mothers
Terminally ill patients
Patients below 30 years and above 60 years of age
Patients who fail to give written informed consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale (VAS)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Rescue Medication Use |
1st day, 10th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mizaj (temperament assessment) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/04/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Osteoarthritis (OA), referred to as Waja al Mafasil in Unani medicine, is a degenerative joint disorder that commonly affects the knee, causing pain, stiffness, and impaired mobility. This randomized controlled pilot study aims to evaluate the efficacy of Inkibab (medicated steam therapy) in treating knee osteoarthritis. The study aims to compare the therapeutic effects of Inkibab with Unani medicines-Babuna (Matricaria chamomilla L.), Nakhuna (Trigonella glabra subsp. uncata (Boiss. & Noe) Lassen), and Gul-e-Tesu (Butea monosperma (Lam.) Kuntze) compared to plain water steam therapy. A total of 10 patients aged 30-60 years, diagnosed with knee OA, will be randomly divided into two groups. Group A (Test group) will receive medicated steam therapy, while Group B (Control group) will undergo plain water steam therapy. Both groups will receive therapy for 10 minutes daily over 10 days. Efficacy will be assessed using the Visual Analogue Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and rescue medication use. Safety will be monitored through pre- and post-treatment investigations. This study aims to assess the comparative efficacy of Inkibab with Unani medicines compared to non-medicated steam in osteoarthritis symptom relief, and will also help in substantiating the principles of Unani medicine in which murkhi (laxity-producing drugs) and muhallil (resolvent) drugs are prescribed for symptom-relief in osteoarthritis. |