| CTRI Number |
CTRI/2025/02/080741 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2025 |
| 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 neck pain in adults |
|
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines in Q-potency in Treatment of Cervical spondylosis: A
Double-blind, Randomized, Placebo-controlled, Trial.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1318-3841 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHABNAM REYAZ |
| Designation |
Postgraduate Trainee |
| Affiliation |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department Practice Of Medicine, Room No-17 and 21
265-266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
8276857991 |
| Fax |
|
| Email |
reyaz.shabnam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr HIMANGSU HAIT |
| Designation |
PhD(Homoeopathy), MD (Homoeopathy), PROFESSOR,HOD, PRACTICE OF MEDICINE. |
| Affiliation |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL,
265-266, Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433565680 |
| Fax |
|
| Email |
haitdrhimangsu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SHABNAM REYAZ |
| Designation |
Postgraduate Trainee |
| Affiliation |
THE CALCUTTA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department Practice Of Medicine, Room No-17 and 21
265-266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India |
| Phone |
8276857991 |
| Fax |
|
| Email |
reyaz.shabnam@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 |
| SHABNAM REYAZ |
The Calcutta Homoeopathic Medical College and Hospital |
Department Practice Of Medicine OPD no 17 and 21, 265-266, Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata
WEST BENGAL |
8276857991
reyaz.shabnam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 with concomitant care |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of one non-medicated globule no.10 is to be dissolved in 100 ml of dist. Water with addition of some rectified spirit and mixed well to make 7 doses regularly or as required then the vial is succussed 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. Patients will be advised to refrain from taking tea, coffee, alcoholic beverages like whisky, brandy etc, and foods possessing medicinal qualities like onion, pepper, cloves, cinnamon, ginger and bitter substance, and old rancid foods etc. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of therapy: 3months. |
| Intervention |
Individualized homoeopathic medicines in Q potency with concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in Q potency, as decided appropriate to the case or condition. In Q potency scale one medicated globule no.10 of the indicated remedy is dissolved in 100 ml of dist. Water with addition of some rectified spirit and mixed well to make 7 doses regularly or as required then the vial is succussed 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. Patients will be advised to refrain from taking tea, coffee, alcoholic beverages like whisky, brandy etc, and foods possessing medicinal qualities like onion, pepper, cloves, cinnamon, ginger and bitter substance, and old rancid foods etc. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of therapy: 3months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age group between 18 to 65 years.
2. Patients with clinical findings and radiological findings for cervical spondylosis.
3. Patients of both sexes.
4. Patients willing to give consent to take homoeopathic treatment.
5. Patients with mild to moderate degenerative radiological changes.
6. Patients not having any major disorder associated with cervical spondylosis.
7. Literate patients; able to read English or Bengali, Hindi
|
|
| ExclusionCriteria |
| Details |
1. Patients having major life-threatening disorder associated with cervical spondylosis
2. Pregnant and puerperal women, and lactating mothers.
3. Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life.
4. Other non-specific neck pain lesion, acute neck strain, or whiplash injury.
5. Patient under other medication for the same complaint especially for 6 weeks.
|
|
|
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 |
| Numerical Rating Scale (NRS) |
At baseline, every 4 weeks, upto three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neck Disability Index (NDI) questionnaire |
At baseline, every 4 weeks, upto three months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
20/02/2025 |
| 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)
|
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 - NO
|
|
Brief Summary
|
Cervical Spondylosis is a wide spread medical condition that significantly impacts patients quality of life. Cervical spondylosis is a degenerative disease that typically develops as a consequence of ligament and facet joint disorders. Its common symptoms include neck pain, numbness in the root innervation area, nausea, vomiting, vertigo and other related symptoms. In the general population the patients prevalence of neck pain ranges from 0.4 % to 41.5 %, the 1 year incidence ranges from 4.8% to 79.5% and lifetime prevalence may be as high as 86.8%. Age is the most common risk factor for cervical spondylosis. The condition is very common in patients who are middle aged and older. Conservative treatment with analgesics only provides temporary relief. Non-steroidal anti-inflammatory medication used to treat pain and inflammation have limitation since unpleasant side effects occur frequently. Where as in Homoeopathic treatment with individualized medicines, the effectiveness of the treatment with regards to improving the daily life activities in patients suffering from cervical spondylosis is higher. Our aimed to evaluate effects of Homoeopathic medicines beyond placebo by conducting 3- month Double-Blind, Randomized (2:1) , Placebo-controlled Trial of individualized Homoeopathic Medicines i Q potency against placebo at The Calcutta Homoeopathic Medical College and Hospital on 140 participants with Cervical Spondylosis symptoms. For Primary outcome assessment Numerical Rating Scale (NRS) scale is administered and for secondary outcome Neck disability Index Questionairre is taken. |