| CTRI Number |
CTRI/2018/04/013395 [Registered on: 20/04/2018] Trial Registered Prospectively |
| Last Modified On: |
09/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homeopathic treatment of knee osteoarthritis |
|
Scientific Title of Study
|
An open randomized controlled clinical trial evaluating the role of additive mother tinctures to individualized homoeopathic treatment of knee osteoarthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abijit Chattopadhyay |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
7003547446 |
| Fax |
|
| Email |
drac.nih@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anaitullah Ahmad Mir |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
Kolkata
WEST BENGAL
700106
India |
| Phone |
9419039499 |
| Fax |
|
| Email |
civildefence12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anaitullah Ahmad Mir |
| Designation |
Postgraduate Trainee |
| Affiliation |
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India |
| Address |
OPD room no. 12 and 13, Dept. of Homoeopathic Materia Medica;
Block GE, Sector III, Salt Lake, Kolkata
WEST BENGAL
700106
India |
| Phone |
9419039499 |
| Fax |
|
| Email |
civildefence12@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India; Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy Ministry of AYUSH Govt of India |
| Address |
Block GE, Sector III, Salt Lake, Kolkata 700106, West Bengal |
| 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 |
| Abhijit Chattopadhyay |
National Institute of Homoeopathy, Govt. of India |
OPD room no. 12 and
13, Dept. of Homoeopathic Materia Medica; Block GE,
Sector III, Salt Lake,
Kolkata 700106
Kolkata
WEST BENGAL |
7003547446
drac.nih@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of National Institute of Homoeopathy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Knee osteoarthritis, (1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v ethanol) in 5 ml of distilled water; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. Medicines are to be taken orally on clean tongue with empty stomach. Duration of therapy: 6 months |
| Intervention |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies plus one of the four following mother tinctures as indicated: Angustura vera, Guaiacum, Stellaria media, and Formica rufa |
Indicated homeopathic medicines in centesimal or fifty millesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of a single drop of the indicated medicine (preserved in 90% v/v ethanol) in 5 ml of distilled water; dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single medicated cane sugar globules of poppy seed size (no. 10) shall be dissolved in 90 ml distilled water with addition of 2 drops of 90% v/v ethanol; 16 doses to be marked on the vial; each dose of 5 ml to be taken after 10 uniformly forceful downward strokes to the vial in 45 ml normal water in a clean cup, to stir well, to take 5 ml of this liquid orally, and to discard rest of the liquid from the cup. Mother tinctures will be administered in individualized dosage (10-20 drops once-thrice daily in half cup of normal water). The following mother tinctures will be used as per indications:
1. Angustura vera
2. Guaiacum
3. Stellaria media
4. Formica rufa
Medicines are to be taken orally on clean tongue with empty stomach. Duration of therapy: 6 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 40-70 years
2. Both sexes
3. Diagnosed knee osteoarthritis as per American College of Rheumatology (ACR) clinical or radiographic classification criteria (sensitivity 91%; specificity 86%):
a) Knee pain
b) At least 1 of 3: age more than 50 yrs, stiffness less than 30 min, and crepitus on knee motion
c) Osteophytes on x-ray knee (AP/lateral view)
4. 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
5. Providing written informed consent
6. Literate patients; ability to read English and/or Bengali |
|
| ExclusionCriteria |
| Details |
1. Severe degeneration of knee joint with marked joint narrowing, varus, or valgus deformity of knee (>12°), evidenced by imaging or other evidences and requiring surgical intervention
2. Non-ambulant patients
3. Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease, specific arthropathy, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs)
4. Intra-articular injections within 2 wk before study entry
5. Transplanted knees
6. Recent significant knee surgery within last 6 months
7. Patients who are too sick for consultation
8. Unwilling to take part and not giving consent to join the study
9. Unable to read patient information sheet
10. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life
11. Pregnancy and lactation
12. Substance abuse and/or dependence
13. Self-reported immune-compromised state, and
14. Undergoing homeopathic treatment for any chronic disease within last 6 months |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bengali version of the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire |
At baseline, after 3 months, and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Five individual KOOS subscale scores – pain, other symptoms, activity of daily living (ADL), sport or recreation, and knee-related quality of life (QOL) |
At baseline, after 3 months, and after 6 months |
| Frequency of add-on Paracetamol and/or NSAIDs (oral/topical) use |
6 months |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
Final Enrollment numbers achieved (Total)= "128"
Final Enrollment numbers achieved (India)="128" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
26/04/2018 |
| Date of Study Completion (India) |
07/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Osteoarthritis (OA) is a heterogeÂneous group of
degenerative joint disease of multi-factorial origin, characterized by
defective integrity and progressive loss of articular carÂtilage, sub-chondral
bone remodelÂling, joint space narrowing and bone spur formation, as well as
synovial inflammation. Pain and functional impairment are the key
domains of the burden of suffering experienced by people with OA that is of
primary concern, and that burden can be sigÂnificant, and taken together they
ofÂten exert a significant reduction in quality of life. Since the last decade, recommendations for
managing OA have focused persistently on relievÂing pain and stiffness and
improving physical function as important goals of therapy. However, conventional drug therapy for OA
successfully reÂlieves pain only, alongside producing adverse gastrointestinal
and carÂdiovascular effects, especially with long-term use. Although clinical guidelines recommend
paracetamol as first line analgesic drug for knee osteoarthritis, high quality
evidence (meta-analysis of RCTs comparing the efficacy and safety of
paracetamol with placebo) suggest Paracetamol as ineffective in the said
condition, provides minimal short term benefit, but nearly four times more
likely to have abnormal results on liver function tests compared to placebo. Nonpharmacologic modalities strongly recommended
for the management of knee OA were aerobic, aquatic, and/or resistance
exercises as well as weight loss for overweight patients. Thus controversies regarding efficacy of the
mainstay pharmacological agent and inadequacy of outcomes, people frequently
refer to CAM therapies and homeopathy. However, effectiveness of homeopathic
treatment strategies, especially classic/individualized and specific mother
tinctures has remained under-researched. A systematic review of clinical trials of osteoarthritis identified
8 controlled trials published during 1980-2013 using ‘complex homoeopathy’ and ‘combination
formulae’. Overall results of the review showed homoeopathic complexes having a
clear advantage in the treatment of osteoarthritis; however, the eviÂdence was not
convincing enough to arrive at a definite conclusion because of methodological
inconsistencies and insufficient trial reporting. Though mother tinctures are frequently used as adjunctive to treat OA in homeopathy, their effectiveness has not been explored till date. In this prospective, open, randomized, two parallel arms,
pragmatic, clinical trial, 128 patients suffering from diagnosed OA knee will be randomized to either individualized homeopathy plus mother tincture arm (verum; IH + MT; n=64) or individualized homeopathy alone (control; IH; n=64). Outcomes will be measured in terms of Knee injury and Osteoarthritis Outcome Score
(KOOS), and five individual KOOS subscale scores – pain, other
symptoms, ADL, sport/recreation, and QOL, measured at baseline, after 3 months and 6 months, and frequency of add-on Paracetamol and/or NSAIDs (oral/topical)
during study period of 6 months. Comparative analysis will be carried out in the end to detect group differences, if any. Results will be published in scientific journals. |