| CTRI Number |
CTRI/2022/01/039286 [Registered on: 10/01/2022] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of the Homoeopathic Medicine Ruck-Pain" in the treatment of Spondylosis |
|
Scientific Title of Study
|
An Open Label Prospective Randomized Controlled Study to Assess the Efficacy of the Homoeopathic Formulation ‘Ruck– Pain’ in the Treatment of Spondylosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr H Venkatesan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital Salem |
| Address |
Department of Practice of Medicine, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO,
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H Venkatesan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital Salem |
| Address |
Department of Practice of Medicine, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO,
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr H Venkatesan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital Salem |
| Address |
Department of Practice of Medicine, Vinayaka Missions Homoeopathic Medical College and Hospital, NH 47, Sankari Main Road, Seeragapadi PO,
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Willmar Schwabe India Pvt. Ltd.
A-36, Sector 60,
Noida,
Uttar Pradesh,
India.
Pin-201304. |
|
|
Primary Sponsor
|
| Name |
Dr Willmar Schwabe India Pvt Ltd |
| Address |
A-36, Sector 60,
Noida,
Uttar Pradesh,
India.
Pin-201304. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vinayaka Missions Homoeopathic Medical College and Hospital |
NH47, Sankari Main Road, Seeragapadi PO, Salem, Tamilnadu - 636308 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr H Venkatesan |
Vinayaka Missions Homoeopathic Medical College and Hospital |
Room No : 3 D - Dept of Practice of Medicine OPD Unit, Ground Floor, Hospital Block, VMHMCH, NH47, Sankari main Road, Seeragapadi PO
Salem
TAMIL NADU |
9865134561
venkathompath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (2) ICD-10 Condition: M47||Spondylosis, (3) ICD-10 Condition: M483||Traumatic spondylopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ruck-Pain: Homoeopathic Formulation Medicine approved by Office of the Commissioner Food Safety and Drug Administration, UP vide Letter No Drug/4706/2456 dated 30.07.2019 |
20 Drops of Medicine in 10 ml of Water will be prescribed orally in morning & night every day before food to each patient for Minimum 90 days duration. |
| Comparator Agent |
Standard Homoeopathic Medicine |
Indicated Homoeopathic Medicines from the the process of Repertorization will be prescribed according to the
Homoeopathic Principles of Symptom Similarity
& Guiding symptoms. The medicines will be Prescribed orally to the patients in Morning and Night before food according to the Homoeopathic Posology Guidelines. Treatment will be given for minimum 90 Days according to the Health Status of the Patients . |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and / or Radiologically Diagnosed Spondylosis Patients. |
|
| ExclusionCriteria |
| Details |
Congenital Spinal anomalies; fracture spine; advanced degenerative spinal conditions; severe neural cord compression; severe bony ankylosis; patients with advanced neurological symptoms; cervical rib. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptomatic Relief of the pain
Improvement in the Mobility of the Patient |
90 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of life of the patient, Improvement in patient mobilization, etc., |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2022 |
| Date of Study Completion (India) |
30/11/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spondylosis is a type of arthritis spurred by wear and tear to the spine. It happens when discs and joints degenerate, when bone spurs grow on the vertebrae, or both. These changes can impair the spine’s movement and affect the nerves and other functions. Ruck-Pain Homoeopathic Formulation Medicine Produced and Marketed by Dr Willmar Schwabe India Pvt Ltd acts on Spinal Disorders. This Proposed Clinical Trial aims at its Clincial Verification. |