| CTRI Number |
CTRI/2022/06/043506 [Registered on: 27/06/2022] Trial Registered Prospectively |
| Last Modified On: |
24/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of lumbar spondylosis |
|
Scientific Title of Study
|
Efficacy of individualized homoeopathic medicines in Q-potency in treatment of lumbar spondylosis: a double-blind, randomized, placebo-controlled, clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUMANTA KAMILA |
| Designation |
Post graduate trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of practice of Medicine; OPD Room no 14; 265-266,
Acharya Prafulla Chandra Road, Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
06290035667 |
| Fax |
|
| Email |
sumantakamila5350@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HIMANGSU HAIT |
| Designation |
MD (Homoeopathy) PhD Professor, HOD (Practice of Medicine) |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice Of Medicine,OPD Room No-14. The Calcutta
Homoeopathic Medical College and Hospital, Govt of West Bengal
265 266 Acharya Prafulla Chandra Road
Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433565680 |
| Fax |
|
| Email |
haitdrhimangsu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HIMANGSU HAIT |
| Designation |
MD (Homoeopathy) PhD Professor, HOD (Practice of Medicine) |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice Of Medicine,OPD Room No-14. The Calcutta
Homoeopathic Medical College and Hospital, Govt of West Bengal
265 266 Acharya Prafulla Chandra Road
Kolkata
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433565680 |
| Fax |
|
| Email |
haitdrhimangsu@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital,265-266, Acharya Prafulla Chandra
Road, Kolkata 700009, West Bengal |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265-266, Acharya Prafulla Chandra
Road, Kolkata 700009, 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 |
| SUMANTA KAMILA |
The Calcutta Homoeopathic Medical College and Hospital |
Department of practice of Medicine; OPD Room no 14; 265-266,
Acharya Prafulla Chandra Road, Kolkata
Kolkata
WEST BENGAL
700009
India
Kolkata
WEST BENGAL |
06290035667
sumantakamila5350@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Calcutta Homoeopathic Medical College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of
one globule no :10 of canesugar dissolved in 120 ml (8 table spoonful) of dist. Water with addition of some rectified
spirit then the vial is succused and after that one table spoon(15 ml) of the solution is taken and put in a glass of
water of about 120ml (8table spoonful). This is stirred thoroughly and from it a dose -5ml(1 tea spoonful) is given
to the patient , to be taken orally in empty stomach dose, & repeated depending upon the individual requirement of
the case.
Duration of therapy:6 months. |
| Intervention |
Individualized homoeopathic
medicines in Q(fifty millesimal)
potencies |
Intervention is planned as administering indicated homoeopathic medicines in Q-(50 millesimal ) potency, as
decided appropriate to the case or condition. In 50 millesimal scale one globule no :10 of the indicated remedy is
dissolved in 120 ml (8 table spoonful) of dist. Water with addition of some rectified spirit then the vial is succused
and after that one table spoon( 15 ml) of the medicinal solution is taken and put in a glass of water of about 120ml
( 8table spoonful). This is stirred thoroughly and from it a dose-5ml(1 tea spoonful) is given to the patient , to be
taken orally in empty stomach dose and repeated depending upon the individual requirement of the case.
Duration of therapy:6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with radiological diagnosis of lumbar spondylosis (2022 ICD-10-CM Diagnosis
Code M47.816) Spondylosis w/o myelopathy or radiculopathy, lumbar region
2. Patients who have not taken any treatment since at least 2 weeks for lumbar spondylosis.
3. Literate patients; can read Bengali and/or English
4. Providing written informed consent to participate in the trial
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from severe degenerative changes as found in radiological findings of lumbar
spondylosis.
2. Patients having major life threatening disorder associated with lumbar spondylosis
3. Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality
of life.
4. Patients who are too sick for consultation.
5. Pregnant and puerperal women, and lactating mothers.
6. Substance abuse and/or dependence
7. Self-reported immune-compromised state
8. Undergoing homoeopathic treatment for any chronic disease within last 6 months. |
|
|
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 |
| Visual analog scale (VAS) for pain. |
At baseline, after 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oswestry disability index |
At baseline, after 3 months and 6 months |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/06/2022 |
| 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
|
None yet; to be published later. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Degenerative disease of the lumbar spine is a significant
cause of disability in the world; In the 2010 Global Burden of Disease (GBD)
Study, It has been found that 266 million individuals (3.63%) worldwide have
Degenerative spine disease and LBP each year; Conventional medical treatment
like NSAIDS and Epidural steroid injections (ESI) have become a common
interventional strategy in the management of lumbar spondylosis and these
medications are having deleterious effects like large intestinal ulcers,
bleeding, perforation, non-specific colitis and meningitis, arachnoiditis
respectively. CAM (Complementary/ Alternative medicine) therapy is being
popular in patients with musculoskeletal disorders including low back pain. Study
in homoeopathy regarding lumbar spondylosis is very scarce.
In order to detect the efficacy of individualized
homeopathic medicines in Q-potency in
treatment of lumbar spondylosis, this double blind, randomized,
placebo-controlled, two parallel arms, clinical trial will be conducted on 60
patients at The Calcutta Homoeopathic Medical College and Hospital. Patients
will be randomized to receive either individualized homeopathic medicines in Q-
potencies, or identical looking placebo.
The outcome measures –visual analog scale(primary), Oswestry
disability index (secondary) will be assessed at baseline, after 3 months,
after 6 months of treatment. A specially designed Microsoft Office Excel spread
sheet (master chart) shall be used for data extraction and shall be subjected
to statistical analysis for measuring the group differences. Results will be
published in scientific journals. |