| CTRI Number |
CTRI/2026/03/106090 [Registered on: 12/03/2026] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of Valmilagu Chooranam and Siddhar Yoga Practices in the Management of Cervical Spondylosis |
|
Scientific Title of Study
|
An open labelled double arm non randomised Phase II clinical trial to evaluate the efficacy of Valmilagu Chooranam (Internal Medicine)and Valmilagu Chooranam ( Internal Medicine) with Siddhar Yoga Muraigal in the Management of Cegana Vatham ( Cervical 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 R T SAKTHI |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Second Year
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College and hospital
Tirunelveli
Tamilnadu
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9677340255 |
| Fax |
|
| Email |
sakthirohin078@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mahalakshmi MD Siddha |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College and hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Mahalakshmi MD Siddha |
| Designation |
Professor and HOD |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College and hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9942061169 |
| Fax |
|
| Email |
drmahalakshmi67@gmail.com |
|
|
Source of Monetary or Material Support
|
| The OPD and IPD facilities and Central library of Government Siddha Medical College , Palayamkottai , Tirunelveli, Tamilnadu, India 627002 |
|
|
Primary Sponsor
|
| Name |
Dr R T Sakthi |
| Address |
Second year
Department of Siddhar Yoga Maruthuvam
Government siddha medical College and hospital Palayamkottai
Tirunelveli
Tamilnadu
India 627002 |
| 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 R T Sakthi |
Government Siddha Medical College and hospital Palayamkottai |
Department of Siddhar Yoga Maruthuvam
Government Siddha Medical College and hospital
Palayamkottai
Tirunelveli
Tirunelveli
TAMIL NADU |
96773 40255
sakthirohin078@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee-Govt siddha medical College and hospital Palayamkottai |
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 |
| Intervention |
Valmilagu Chooranam ( Internal Medicine) |
Oral administration of 2 grams with lukewarm water twice a day for a duration of 48 days |
| Comparator Agent |
Valmilagu Chooranam (Internal medicine) with Siddhar Yoga Muraigal |
Oral administration of 2 grams of Valmilagu Chooranam with Luke warm water twice a day along with the practice of Siddhar Yoga Muraigal for a duration of 48 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Complain about pain behind the neck (in the area of trapezius)
Radiating pain to the upper limbs
Numbness and weakness in arms, hands and fingers
Muscle spasms in neck and shoulders
Osteophyte formation
Lhermitte’s sign and Spurling’s test – Positive
Shoulder abduction pain relief sign – Positive |
|
| ExclusionCriteria |
| Details |
Trauma
Malignancy
Pregnancy and lactation
Adhesive Capsulitis
Psychogenic Neck pain
Inflammatory disease
Post operative conditions
Congenital anomalies
Patients with systemic illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Through this trial, the therapeutic effectiveness of the trial drug and Siddhar Yoga
Maruthuva Muraigal towards the management of Cegana vatham can be manifested. |
Baseline(0th day) and the end of the intervention period (48th day) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction of pain is assessed by Visual Analogue Scale .
• Improvement in range of movements, stiffness is assessed by using Neck disability
index.
• Comparing the clinical symptoms and physical examinations before and after
treatment.
• Preference of Yogic Management as line of treatment for Cegana vatham can be
acknowledged. |
Baseline(0th day) and the end of the intervention period (48th day) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
23/03/2026 |
| 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="1"
Months="6"
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
|
It is an open labelled double arm non randomised phase II clinical trial to evaluate the efficacy of
Valmilagu Chooranam and Valmilagu Chooranam with Siddhar Yoga Maruthuvam Muraigal
Group A will be given oral administration of 2 grams of Valmilagu Chooranam (Internal medicine) with
Luke warm water twice a day for a duration of 48 days
Group B also be given oral administration of 2 grams of Valmilagu Chooranam with Luke warm water
along with the practice of Siddhar Yoga Maruthuvam Muraigal for a duration of 48 days |