| CTRI Number |
CTRI/2024/05/067979 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Yogasana and Greeva Vasti in the management of cervical spondylosis |
|
Scientific Title of Study
|
A clinical study of Yogasana and Greeva Vasti in the management of 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 |
NIDHI |
| Designation |
Research scholar |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
Department of Panchakarma Faculty Of Ayurveda
Institute of Medical Sciences Banaras Hindu University Varanasi
UTTAR PRADESH 221005 INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
6261111648 |
| Fax |
|
| Email |
nidhichandrakar571@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof JAI PRAKASH SINGH |
| Designation |
Professor |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
Department of Panchakarma Faculty Of Ayurveda
Institute of Medical Sciences Banaras Hindu University Varanasi UTTAR PRADESH 221005 INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415814351 |
| Fax |
|
| Email |
drjpsingh98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof JAI PRAKASH SINGH |
| Designation |
Professor |
| Affiliation |
BANARAS HINDU UNIVERSITY |
| Address |
Department of Panchakarma Faculty Of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi UTTAR PRADESH 221005 INDIA
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415814351 |
| Fax |
|
| Email |
drjpsingh98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal hospital Indian Medicine Wing
Department of Panchakarma Faculty of Ayurveda
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 India. |
|
|
Primary Sponsor
|
| Name |
Department of Panchakarma Faculty of Ayurveda |
| Address |
Institute of medical sciences Banaras Hindu University Varanasi Uttar Pradesh 2210005 India
Sir Sunderlal hospital OPD NO 16 C Indian Medicine Wing Faculty of Ayurveda
Department of Panchakarma |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Jai Prakash Singh |
Sir sunderlal Hospital |
OPD no 16c Indian Medicine Wing Department of Panchakarma Faculty of Ayurveda IMS BHU Varanasi UTTAR PRADESH
Varanasi
UTTAR PRADESH |
9415814351
drjpsingh98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of medical sciences Banaras Hindu University varanasi Institute of medical sciences Banaras Hindu University Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M472||Other spondylosis with radiculopathy. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | grIvAbastiH, गà¥à¤°à¥€à¤µà¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Charaksamhita, Procedure details: GREEVA VASTI: - Local experiment on the cervical region will be given with Narayana oil. It gives relief in pain and stiffness. Patient was let to lie down on the table in prone position. Then the patients will be asked to drape clothes so that cervical region could be exposed properly. taking ample quantity of water, the dough of black gram powder was prepared. This dough will be used to form a wall which was 2 inches height and 4 inches diameter on the cervical area. This will be filled with h)
(1) Medicine Name: Narayan oil, Reference: Ayurveda Sar Sangrah, Route: Topical, Dosage Form: Taila, Dose: 250(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group minimum 20 years and under 60 years
Both genders will be included with presenting symptoms of Cervical Spondylosis
According to NDI (NECK DISABILITY INDEX) level of mild and moderate patients included in this study
Patients who are fit for snigdha swedana
Patients with consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Age less than 20 years and more than 60 years
Patients with any type of comorbidity like diabetes heart disease etc
Need surgical care
Pregnant women and lactating mothers
Any type of bone fracture
Presenting symptoms of paralysis
Intake of any medicine for chronic disorders
High blood pressure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
BMI
Blood Pressure
Pulse rate
Respiration rate
Temperature
x ray of cervical spine
|
Three months with 3 follow ups of one month each
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
complete hemogram
fasting blood sugar |
Neck Disability Index at baseline & after the 1 month interventions |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/07/2024 |
| 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="1"
Months="1"
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 problem of cervical spondylosis
affects people all over the world and in India. About 10 million persons per
year affected in India alone. The incidence of neck pain in adults is 25-50%
per year. Cervical spondylosis is a disease which affects a person’s daily
routine. The person suffering from it experiences difficulty in doing his daily
routine and they unable to do their work properly.
Other treatments to manage spondylosis are medicines. Modern medicines (non-steroidal
anti-inflammatory drugs) NSADIs Which can be managed but if used for a long
time, it causes various diseases related to gastritis, liver, kidney, heart as
its side effects. Medicines, surgery and other conservation treatments have not
been more effective, therefore, there is a need for a treatment which is
helpful in manage the cervical spondylosis and without any side effects.
In the present time, yoga is liked by more
group of peoples and effective in getting rid of the disease, which can be
helpful in management of cervical pain and stiffness. Eliminates and increases
physical activity. Yoga originated in India but it is famous all over the
world. Yoga is effective to manage lifestyle disorders. Is cause effective easy
can afford any person. Various activities of Yoga, asanas, pranayama,
meditation etc. achieve physical and mental health. According to the Hatha
yogic text, there is a description of attaining health through the practice of
asanas.
According to Ayurveda the manage for the spine
is considered to be the Greeva Vasti, which is type of Sneha swedana given with
heated medicated oil. Hence for the quick treatment of cervical spondylosis, If
Greeva Vasti and Yoga are given combine then it can be more effective for
Cervical Spondylosis. Other system of treatments is more expensive in
comparison to Yogasana and Greeva Vasti and other treatments are given in
hospitals and other places where the patient and his family also have to face
financial problems Yogasana and Greeva Vasti is such a treatment which can be
given at low cost at home even without a medical institution and proper
benefits can be obtained. In this, the patient does not feel any pain and it
does not have any side effects. |