CTRI Number |
CTRI/2023/11/060046 [Registered on: 21/11/2023] Trial Registered Prospectively |
Last Modified On: |
22/09/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
To study the effect of Ayurvedic treatment in the improvements of patients with Cervical Spondylitis. |
Scientific Title of Study
|
To study the Safety and Efficacy of classical Ayurvedic treatment in the functional improvements of
patients with Cervical Spondylitis |
Trial Acronym |
Nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
MHC/CT/23-24/011 Version 1.00 dated 5th July 2023. |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Amol S Gothwad |
Designation |
Consultant |
Affiliation |
Lokmanya Medical Research Centre and Hospital |
Address |
Lokmanya Medical Research Centre and Hospital Fourth floor OPD no
401 314 B Telco Road Chinchwad
Pune MAHARASHTRA 411033 India |
Phone |
9766400243 |
Fax |
|
Email |
dr.amolgothwad001@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vaishnavi Patil |
Designation |
Senior manager |
Affiliation |
Mprex Healthcare Pvt. Ltd. |
Address |
Mprex Healthcare Pvt Ltd Office No 501 514 Crossroads Building
Bhumkar Square Wakad
Pune MAHARASHTRA 411057 India |
Phone |
9834585994 |
Fax |
|
Email |
vaishnavi@mprex.in |
|
Details of Contact Person Public Query
|
Name |
Dr Vaishnavi Patil |
Designation |
Senior manager |
Affiliation |
Mprex Healthcare Pvt. Ltd. |
Address |
Mprex Healthcare Pvt Ltd Office No 501 514 Crossroads Building
Bhumkar Square Wakad
MAHARASHTRA 411057 India |
Phone |
9834585994 |
Fax |
|
Email |
vaishnavi@mprex.in |
|
Source of Monetary or Material Support
|
Mprex Healthcare Pvt.Ltd. Wakad, pune |
|
Primary Sponsor
|
Name |
Mprex Healthcare Pvt.Ltd. Wakad, pune |
Address |
Office no.501,514 Crossroads, Bhumkar Square, Wakad, Pune
-411057
|
Type of Sponsor |
Research institution |
|
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 Amol Gothwad |
Lokmanya Medical Research Centre |
Fourth floor OPD NO 401,
314 B Telco Road,
Chinchwad Pune MAHARASHTRA |
9766400243 - dr.amolgothwad001@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee of Lokmanya Medical Research Centre |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M452||Ankylosing spondylitis of cervicalregion, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Kshirbala oil |
10-20 ml to be massaged on affected area once a day for 14 days. |
Comparator Agent |
Standard Kshirbala Oil |
10-20 ml to be massaged on affected area once a day for 14 days. |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Male and female subjects 30-60 years of age (both inclusive)
2.Subject diagnosed with cervical spondylitis with or without nerve compression for more than three months.
3.Pain in the neck and shoulder, and difficulty with neckline rotation, flexion, extension,etc.
4.Subject have Muscle spasm, Numbness, Tingling sensation, and joint stiffness.
5.Be willing to refrain from taking analgesics, anti-inflammatory agents, corticosteroids, muscle relaxants, etc. during the entire trial.
6.An ambulatory subject can provide verbal and written consent and is ready to comply with all study procedures. |
|
ExclusionCriteria |
Details |
1. Patients suffering from a pathological condition like a Bone tumor, Tuberculosis spine, etc.
2. History of injury to the cervical spine with the major surgical intervention will be excluded.
3. Female subjects, who are pregnant, breastfeeding, or planning to become pregnant.
4. Patients who are unable to walk without support and/or confined to a wheelchair or bedridden.
5. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
1. To study Panchakarma Essentials efficacy in
reducing cervical spondylitis pain.
2. To study the patient’s relief from stiffness &
other associated symptoms |
Seven Sessions in two weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1. To study improvement in the Cervical Range
of Movement.
2. To assess the improvement in the Quality of
life of a patient |
Seven Sessions in two weeks |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
N/A |
Date of First Enrollment (India)
|
02/09/2024 |
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="0" Months="3" 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 general term affecting the spinal disc in the neck. The inter-vertebral spaces are affected most and start at the degeneration of discs resulting in a reduction of inter-vertebral disc space. It develops restricted cervical spine movement in the neck due to pain and swelling. The study aims to assess the Safety and Efficacy of classical Ayurvedic treatment in the functional improvements of patients with Cervical Spondylitis. The therapeutic effect is assessed by comparing relief from stiffness and other associated symptoms. Adverse effects reported by patients during treatment will be recorded. |