| CTRI Number |
CTRI/2024/03/064632 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment for depression and knee pain |
|
Scientific Title of Study
|
Evaluating the efficacy of individualized homoeopathic medicines in reducing
depression, anxiety, and stress in adults with osteoarthritis of knee: a double-blind, randomized, placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1304-6217 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghamala Chakraborty |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept. of Practice of Medicine, 265,266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9836220240 |
| Fax |
|
| Email |
dr.meghamalachakraborty@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept. of Practice of Medicine, 265,266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Chattopadhyay |
| Designation |
Principal and Administrator |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Dept. of Practice of Medicine, 265,266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital. 265,266 Acharya Prafulla Chandra Road, Kolkata 700009. |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265,266 Acharya Prafulla Chandra Road, Kolkata 700009 |
| 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 Meghamala Chakraborty |
The Calcutta Homoeopathic Medical College and Hospital |
OPD no. 21, Dept. of Practice of Medicine, 265,266 Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata
WEST BENGAL |
9836220240
dr.meghamalachakraborty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of The Calcutta Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: F411||Generalized anxiety disorder, (3) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos and
concomitant care |
This arm will receive placebo,
indistinguishable in appearance from verum. Each dose of placebo shall consist of 4 globules (no. 40) of cane sugar,moistened with rectified spirit,to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients of both groups will receive concomitant care in the
form of general management
which will include ice cube
massage over the painful
knee(s), static quadriceps
exercise (isometric knee
extension, isometric knee flexion, straight leg raise, heel raise), use of knee cap or braces (if required), avoid bending knees and sitting on floor, avoid lifting heavy weights, weight loss if obese etc. Route of administration: Per oral; duration of therapy: 3 months |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies plus concomitant care |
Intervention is planned as
administering indicated
homoeopathic remedy in
centesimal potencies, as
decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no.40) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised
to refrain from handling the
globules or from eating,
drinking, smoking or brushing
teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and the sundry items will be procured . All the enrolled
patients of both groups will
receive concomitant care in the form of general management
which will include ice cube
massage over the painful
knee(s), static quadriceps
exercise (isometric knee
extension, isometric knee
flexion, straight leg raise, heel raise), use of knee cap or braces (if required), avoid
bending knees and sitting on
floor, avoid lifting heavy
weights, weight loss if obese
etc. Route of administration: Per oral; duration of therapy: 3 months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed knee osteoarthritis (ICD-11 code FAO1) as per American College of
Rheumatology (ACR) clinical/radiographic classification criteria45 (sensitivity 91%;
specificity 86%) - history of trauma over knee, knee pain, stiffness less than 30 min, and
crepitus on knee motion, osteophytes on knee x-ray.
2. Age: 50-70 years.
3. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for
depression (five or more symptoms out of nine for 2 weeks including at least one of these:
depressed mood and loss of interest or pleasure) and/ or anxiety (more than three symptoms
out of six including excessive anxiety and worry occurring at least six months, about number
of events or activities) as per American Psychiatric Association (APA)
4. DASS-21 depression score: 10-27 (mild and moderate).
5. Patients of either sex including transgenders.
6. Patients already undergoing regular oral or topical analgesics or NSAID therapy for painful
episodes of osteoarthritis, provided the medications are stopped completely at least 2 weeks prior study entry providing written informed consent voluntarily. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give written consent voluntarily.
2. Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease,
specific arthropathy, hyperuricemia and/or gout, severe axis deviations or instabilities,
joint or skin infections, joint prostheses of the lower limbs).
3. Intra-articular injections within 2 weeks before study entry.
4. Transplanted knees.
5. Recent significant knee surgery within last 6 months.
6. DASS-21 depression score: 0-9 (normal) and above 28 (extremely severe).
7. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or lifethreatening illness affecting quality of life
8. Pregnancy, puerperium and lactation.
9. Vulnerable population – Unconscious, non-ambulatory, too ill for consultation, differently
abled, terminally ill, or critically ill patients, mentally disabled people.
10. Substance abuse and /or dependence
11. Self-reported immune-compromised state, and
12. Undergoing homoeopathic treatment for any chronic disease within last 6 months
13. Simultaneous participation in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DASS-21 (Depression, anxiety, and Stress Scale 21) depression subscale |
Every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DASS-21 (Depression, anxiety, and Stress Scale 21) anxiety and stress subscales |
Every month, up to 3 months |
| KOOS (Knee Injury and Osteoarthritis Outcome Score) |
Every month, up to 3 months |
| MYMOP-2 (The Measure Yourself Medical Outcome Profile revised version) |
Every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
01/04/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.meghamalachakraborty@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Depression, anxiety and stress are common psychological comorbidities that impact the quality of life (QoL) of patients with osteoarthritis. it is the most common musculoskeletal disorder worldwide. Osteoarthritis is characterized by degeneration of the articular cartilage, osteophyte formation, and asymmetric joint space narrowing. These changes often lead to significant pain and disability and create a substantial individual, societal, and economic burden. Depression is common in people with OA, with a prevalence of 20% . It is defined as the presence of sad, empty, or irritable mood. Anxiety is defined as the presence of fear or nervousness about what might happen. In the field of Homoeopathy, no researches have been done yet to actively control of these clinical co-morbidities. A deep analysis of individual constitution and miasmatic background with the guidance of therapeutic and reportorial analysis will enrich the homoeopathic literature. A double-blind, randomized (2:1), Placebo Controlled Trial will be conducted on 110 patients who are suffering from depression, anxiety and stress in adults with osteoarthritis of knee at the outpatient department of The Calcutta Homoeopathic Medical College and Hospital. Assessment will be done by DASS-21 (Depression, Anxiety and Stress 21) depression subscale [primary outcome], DASS-21 (Depression, Anxiety and Stress 21) anxiety and stress subscale, KOOS (Knee Injury and Osteoarthritis Outcome score), MYMOP-2 (Measure Yourself Medical Outcome Profile revised version) [secondary outcome], all to be measured every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals. |