| CTRI Number |
CTRI/2024/09/074171 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Physiotherapy (Not Including YOGA)
Other (Specify) [Nasya (Nasal Administration of Medicated Oil)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Ayurveda Treatment Protocol in neck pain |
|
Scientific Title of Study
|
Efficacy Of Ayurveda Treatment Protocol in Cervical Spondylosis-A Randomized Controlled Trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kartik Sharma |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department Of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
9418235706 |
| Fax |
|
| Email |
shakartik11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
DEAN Faculty of Ayurveda Professor & HOD Department Of Kayachikitsa |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department Of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Basavaraj R Tubaki |
| Designation |
DEAN Faculty of Ayurveda Professor & HOD Department Of Kayachikitsa |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi |
| Address |
Department Of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India
Belgaum
KARNATAKA
590003
India |
| Phone |
9448634660 |
| Fax |
|
| Email |
ayurbasavaraj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kaher Shri BMK Ayurveda Mahavidyalaya Shahapur Belgavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Kartik Sharma |
| Address |
KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India 590003 |
| 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 Kartik Sharma |
KLE Ayuveda Hospital and Medical Research Centre |
Room no 6,7 Department of Kayachikitsa KLE Ayurveda Hospital Shahapur Belagavi 590003
Belgaum
KARNATAKA |
9418235706
shakartik11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M479||Spondylosis, unspecified. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAMÂ (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtanga Hridaya Sootra Sthana Adhaya 20th, Procedure details: Poorva Karma- Patient Is Advised To Lie Down On Nasya Table With Head Low Position.Then Mukhabhyanga With Karpasasthyadi Tail Will Be Done Followed By Nadi Sweda Done To Patient Over Face And Neck With Covering Eyes With Cotton Pads. Pradhana Karma- Patient Is Advised To Lie Down In Supine position With Head Lowered Backward For 45 Degree Angle.Then Mild Lukewarm Karpasasthyadi Tail With Selected Quantity (4ml) Taken In a Dropper And Instilled In one Nostril Followed By Another Nostril.
Pashat Karma- Then The Patient Is Asked To Spit Out Medicine When Reaches The Throat.Gentle Massage Is Done On Forehead Palms And Soles Of The Patient.Patient Then Allowed To Take Rest For 15 Minutes.)
(1) Medicine Name: Karpasasthyadi Tail, Reference: Sahasrayoga, Route: Nasal, Dosage Form: Taila, Dose: 4(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Medication Therapy And Physiotherapy | 0-30 Days:
Physiotherapy(Mechanical Traction One Session 20 min/day for first 7 days) (1st to7th day) Followed by Tab Diclofenac Sodium 50 mg Twice daily for 10 days (8th -17th Day)
Isometric Neck Exercises Initiated At 8th Day
31-60 Days:
Physiotherapy(Mechanical Traction One Session 20 min/day For First 7 days) (31st -37th Days) Followed By Tab Diclofenac Sodium 50 mg Twice Daily For Next 10 days (38th -47th day)
Isometric Neck Exercises up to 60th day
| | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Maharasnadi Kwatha, Reference: Sharangadhara Samhita Madhyam Khanda Chapter 2nd, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: -(2) Medicine Name: Trayodashanga Guggulu, Reference: Bhaishijya Ratnavali Vatavyadhi Rogaadhikara, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with signs and symptoms of Cervical Spondylosis Radiological Changes Suggestive of Cervical Spondylosis Disease.
2.Patient Fit for Nasya.
3.VAS Score of Above 5.
|
|
| ExclusionCriteria |
| Details |
1.Stenosis of the Spinal canal.
2.Myelopathy.
3.Myofacial Pain Syndrome.
4.Known Case of Chronic Diseases (Like Rheumatoid Arthritis SLE Ankylosing Spondylitis) Vertebral Fractures.
History of Neck Surgery.
Uncontrolled Systemic Illness Like Diabetes Mellitus Hypertension or Renal Disorder.
Pregnant and lactating women.
Patient on any medication for Cervical Spondylosis since 4 weeks.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
VAS Visual Analogue Scale
NDI Neck Disability Index |
Baseline,8th,15th,30th,45th and 60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Goniometric Examination
SF-36 Quality of Life |
Goniometric Examination Baseline,8th,15th,30th,45th and 60th Day
SF-36 Quality of Life Baseline 30th and 60th Day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
06/01/2025 |
| 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 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 prevalent age-related condition impacting the neck
vertebrae and discs. Most people
with spondylotic changes of the cervical spine on radiographic imaging remain
asymptomatic, with 25% of individuals under the age of 40, 50% of individuals
over the age of 40, and 85% of individuals over the age of 60 showing some
evidence of degenerative changes. The most frequently affected levels are
C6-C7, followed by C5-C6. Symptomatic
cervical spondylosis most commonly presents as neck pain. In the general
population, the point prevalence of neck pain ranges from 0.4% to 41.5%, the
1-year incidence ranges from 4.8% to 79.5%, and lifetime prevalence may be as
high as 86.8%. According
to the Global Burden of Disease 2015, low back and neck pain remain the leading
cause of years lived with disability (YLD) and the fourth leading cause of disability-adjusted
life years (DALYs).In
this degenerative condition patient suffer pain, difficulty in neck movements
and some time it interferes with day to day activities of patient life. Thus
symptomatic management with NSAIDs and Physiotherapy or neck exercise are proven to be main stay of management
for the cervical spondylosis. Previous Ayurveda studies with such treatment
modalities like greeva basti, Nasya and Shaman Aushadhi’s have shown some good
results in the conditions like manyastambha, greevastambha or vishvachi.
But for improving disability index and quality of life of patient sufficient
clinical data is needed.For reducing neck pain ,improving Neck Disability Index
,improving range of motion and improving quality of life, Nasya with karpasasthyadi
tail and Maharasnadi Kwatha ,trayodashang guggulu as all the
three are mention in the context of vatavyadhi are taken into study to see their effect on specified
symptoms of cervical spondylosis and on all specific parametes like neck
disability index ,range of motion, quality of life.Also considering the
emerging of this disease from young generation to old one and chronicity of the
disease,a long term safe and efficacious medication is required for the
management.Thus its an attempt to see the effect of ayurveda treatmet protocol
on cervical spondylosis management.
|