| CTRI Number |
CTRI/2023/07/055033 [Registered on: 10/07/2023] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate safety & efficacy of Manyawin Capsule in patients with Cervical Spondylosis |
|
Scientific Title of Study
|
"An Open Labelled Prospective Noncomparative Single Arm Clinical Study to Evaluate Safety & Efficacy of Manyawin Capsule in Patients with Cervical Spondylosis" |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKM-MYN-001-23_Version 01_10-May-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
T Ganesh |
| Designation |
Manager |
| Affiliation |
SKM Siddha and Ayurveda Company India Private Limited |
| Address |
SKM Siddha and Ayurveda Company India Private
Limited Saminathapuram Post Modakkuruchi Erode
District Tamilnadu India
Erode
TAMIL NADU
638104
India |
| Phone |
7502178459 |
| Fax |
|
| Email |
research@skmsiddha.org |
|
Details of Contact Person
Scientific Query
|
| Name |
T Ganesh |
| Designation |
Manager |
| Affiliation |
SKM Siddha and Ayurveda Company India Private Limited |
| Address |
SKM Siddha and Ayurveda Company India Private
Limited Saminathapuram Post Modakkuruchi Erode
District Tamilnadu India
Erode
TAMIL NADU
638104
India |
| Phone |
7502178459 |
| Fax |
|
| Email |
research@skmsiddha.org |
|
Details of Contact Person
Public Query
|
| Name |
Brindha Arumugam |
| Designation |
Project Manager |
| Affiliation |
IDD Research Solutions INC |
| Address |
12A First Floor 3rd Sector
HSR Layout Bengaluru Karnataka
Bangalore
KARNATAKA
560102
India |
| Phone |
9894514883 |
| Fax |
|
| Email |
brindha.arumugam@iddresearch.com |
|
|
Source of Monetary or Material Support
|
| SKM Siddha and Ayurveda Company India Private Limited |
|
|
Primary Sponsor
|
| Name |
SKM Siddha and Ayurveda Company India Private Limited |
| Address |
Saminathapuram Post Modakkuruchi Erode District Tamilnadu India 638104 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Yamuna Jeevanandham |
Ashwin Multispecialty Hospital |
No.545, BKR Nagar, Alamu Nagar Road, Sathy Main Road, Coimbatore-641012, Tamil Nadu, India.
Coimbatore
TAMIL NADU |
8778477894
amsh.clinicalresearch@gmail.com |
| Dr Ambrish C |
Medstar Speciality Hospital |
641 17 1 3 Kodigehalli Main road Sahakar Nagar Bangalore Karnataka India 560092
Bangalore
KARNATAKA |
9845895911
drambrishmedstar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ashwin Hospital |
Approved |
| Medstar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: VATABALASAJVARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manyawin Capsule, Reference: Mahabala, Karpasa, Route: Oral, Dosage Form: Khanda /Granules, Dose: 510(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: anupAna), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Male/female patients aged ≥ 18 years and ≤ 65 years at the time of consent;
2) Patients with clinically confirmed diagnosis of cervical spondylosis within the
last 6 months;
3) Patients who have had one or more episodes of neck pain, neck stiffness attack
on average per month for more than 3 months;
4) Patients with NDI score of 20-35 at the time of screening;
5) Patients with VAS score of >5 at the time of screening;
6) Patients displaying a minimum of three of the following symptoms as evaluated
by the physician:
a) Cervical pain aggravated by the movement;
b) Pain in occiput (back of the head), shoulder blades or upper limbs;
c) Retro-orbital or temporal pain;
d) Cervical stiffness;
e) Localized tenderness, pain or numbness of upper limbs
f) Dizziness or vertigo attributed to cervical pain;
7) Patients who are willing to give voluntary written informed consent. |
|
| ExclusionCriteria |
| Details |
1) Patients with known or suspected allergies/hypersensitivities to herbal or
ayurvedic medicines;
2) Patients who are clinically diagnosed with osteoarthritis, rheumatoid arthritis
and ankylosing spondylitis;
3) Patients with known history or diagnosis of advanced cervical radiculopathy,
bony spurs, cervical myelopathy, cervical malignancies and lesions;
4) Patients with severe congenital malformation of cervical vertebra; known
history of cervical injury, cervical surgery, and implanted instrumentation;
5) Patients with history of major neurological disorder such as a stroke,
myasthenia gravis, muscular dystrophy, myotonic dystrophy and sclerosis;
6) Patients with traumatic soft tissue injury to the cervical region in the past 1
year;
7) Patients who are known to be asthmatic or immunocompromised;
8) Patients who are on NSAIDs, DMARDs or any other treatments for cervical
pain for 1 month before screening;
9) Patients with terminally ill and any other condition, in the opinion of the
investigator, which would affect the safety of the patient;
10) Female patients who are breast-feeding/ pregnant, or intends to become
pregnant during the study; |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment-emergent adverse events (TEAEs) (serious/non-serious, expected/unexpected, related/non-related). |
Day 01, Day 60, Day 120, Day 180, Day 210. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Change in Visual Analogue Scale (VAS) score for neck pain, neck stiffness, radiating pain towards shoulders /arms, tingling
sensation of fingers, headache/vertigo
2) Change in Neck Disability Index (NDI) Score
3) Change in Short-form McGill Pain Questionnaire (SF-MPQ)
4) Quality of life Questionnaire SF-36 |
Day 1, Day 60, Day 120, Day 180, Day 210. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/07/2023 |
| Date of Study Completion (India) |
13/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Cervical spondylosis (CS) is a muscular condition or similarly known as osteoarthritis of the spine.It often causes nerve root or spinal compression pains. This can be triggered off by a traumatic experience such as a whiplash injury, old fractures, muscle tension, or by a herniated disc or blood disease. Often, spondylosis specifically affects the facet joints in the spine CS is a chronic degenerative disease which results from progressive biomechanical stress and strain and can present as myelopathy, radiculopathy, axial cervical pain or the combination of the above. However, a proportion of patients having CS can complain about varying degrees of symptoms like vertigo, tinnitus, blurred vision, headache, nausea, vomiting, palpitations, hypertension and gastrointestinal (GI) discomfort Sida cordifolia, is one of the major ingredient of Manyawin capsule. Their roots has shown anti-inflammatory, anti-arthritic and anti-analgesic effect that found to be effective in reducing the symptoms of CS Gossypium herbaceum, is an another major ingredient of the study product. The leaf of this plant was screened and proved to be effective as anti inflammatory and anti-analgesic. Sida cordifolia and gossypium herbaceum being the major ingredients, the study product is expected to treat neck pain associated with CS and its symptoms Total 30 Eligible patients will be enrolled in single arm 180 days for treatment and another 30 days for follow up |