| CTRI Number |
CTRI/2026/01/100172 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Treatment of neck pain using karpoora skin patch for local application, |
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE ANALGESIC EFFECT OF KARPOORA TRANSDERMAL PATCH IN CERVICALGIA |
| 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 P Vaishnavi |
| Designation |
Pg scholar |
| Affiliation |
Government Ayurveda Medical College and hospital mysuru |
| Address |
Postgraduate Department of Ayurveda Samhitha and Siddhantha
Postgraduate Department of Ayurveda Samhitha and Siddhantha
Government
Ayurveda Medical College and hospital Visvesvaraya circle, Sayyajirao road,
Mohalla Mandi
Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
8618662347 |
| Fax |
|
| Email |
vaishnavipnayaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasudev anandrao chate |
| Designation |
Professor |
| Affiliation |
Government Ayurveda Medical College and hospital mysuru |
| Address |
Postgraduate Department of Ayurveda Samhitha and Siddhantha
Postgraduate Department of Ayurveda Samhitha and Siddhantha
Government
Ayurveda Medical College and hospital Visvesvaraya circle, Sayyajirao road,
Mohalla Mandi
Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
9448150212 |
| Fax |
|
| Email |
vachate37@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Vaishnavi |
| Designation |
Pg scholar |
| Affiliation |
Government Ayurveda Medical College and hospital mysuru |
| Address |
Postgraduate Department of Ayurveda Samhitha and Siddhantha
Postgraduate Department of Ayurveda Samhitha and Siddhantha
Government
Ayurveda Medical College and hospital Visvesvaraya circle, Sayyajirao road,
Mohalla Mandi
Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA
570001
India |
| Phone |
8618662347 |
| Fax |
|
| Email |
vaishnavipnayaka@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr P VAISHNAVI |
| Address |
Department of post-graduate studies in Ayurveda Samhitha and Siddhantha, Government
Ayurveda Medical College and hospital Visvesvaraya circle , Sayyaji rao road, Mohalla Mandi Mohalla Mysuru
KARNATAKA
570001
India |
| Type of Sponsor |
Other [self] |
|
|
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 P Vaishnavi |
Government Ayurveda Medical College and hospital mysuru |
Postgraduate Department of Ayurveda Samhitha and Siddhantha
Government
Ayurveda Medical College and hospital Visvesvaraya circle, Sayyajirao road,
Mohalla Mandi
Mysore
KARNATAKA
570001
India
Mysore
KARNATAKA |
08618662347
vaishnavipnayaka@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government ayurveda medical college mysuru ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M608||Other myositis. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Sharangadhara samhita, Procedure details: Karpoora transdermal patch that is a modified form of lepa kalpana is applied to painful neck region onece in a day for 6 hours for total of 5 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 A disorder characterized by marked discomfort sensation in the neck area.
2 Discomfort or more intense forms of pain that are localized to the cervical region. This term generally refers to pain in the posterior or lateral regions of the neck.
3 Painful sensation in the neck area.
4 3.Cervicalgia due to Physical stress, Muscle strain, Poor posture, Cervical spondylosis, Arthritis.
|
|
| ExclusionCriteria |
| Details |
1.Subjects diagnosed with other systemic disorders that interfere with study.
2.Cervicalgia due to neurological origin, Malignancy, Tumour, Fracture and Infection.
3.Pregnant woman and lactating mother.
4.Local skin inflammation or skin diseases at the region of patch application.
5. Skin irritation or allergic reactions to transdermal patches or their components. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessing relief of pain in cervicalgia |
Baseline 1st day before application of patch and 5th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessing relief of pain in cervicalgia |
follow up 10th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
15/01/2026 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The proposed study aims to evaluate the analgesic efficacy of a Karpoora Camphor transdermal patch in treating Cervicalgia neck pain, a highly prevalent condition in the modern era attributed largely to sedentary lifestyles and occupational demands. From an Ayurvedic perspective Cervicalgia is understood to be predominantly a Vata dosha imbalance, consistent with the principle Vatadrute na asthi ruja pain cannot occur without Vata. The treatment therefore focuses on correcting this imbalance. The study utilizes Karpoora a well-known analgesic agent mentioned in classical texts which is a key component of the traditional Vatashoolahara Malaham. Critically, the drug is formulated as a transdermal patch to offer a convenient and easy-to-use mode of administration, ensuring minimal disruption to the busy work schedules of patients, thereby addressing both the therapeutic need and the practical challenges of modern compliance. |