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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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. 
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