| CTRI Number |
CTRI/2020/03/024226 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical evaluate of trayodashanga guggulu and sahacharadi kwatha with and without greeva basti in the management of greevasandhigata vata. |
|
Scientific Title of Study
|
A randomized comparative clinical study to evaluate the efficacy of Trayodashanga Guggulu and Sahacharadi Kwatha with and without Greeva Basti in the management of Greevasandhigata Vata w.s.r. to Cervical Spondylosis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr HML Meena |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa
National Institute of Ayurveda
Madhav Vilas Palace Amer Road
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461297017 |
| Fax |
|
| Email |
hari_mohan68@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr HML Meena |
| Designation |
Associate Professor |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa
National Institute of Ayurveda
Madhav Vilas Palace Amer Road
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9461297017 |
| Fax |
|
| Email |
hari_mohan68@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Kumar |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of Kayachikitsa
National Institute of Ayurveda
Madhav Vilas Palace Amer Road
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9928502551 |
| Fax |
|
| Email |
dr.ashok84@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Madhav Vilas Palace Amer Road Jaipur 302002 |
| 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 |
| Dr Ashok Kumar |
National Institute of Ayurveda Hospital Jaipur |
OPD No 1, 7, 18, 25
Dept. of Kayachikitsa,
Madhav Vilas Palace
Amer Road Jaipur,
302002
Jaipur
RAJASTHAN |
9928502551
dr.ashok84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Greeva Basti |
Greeva Basti with Prasarini Taila daily for 45 min. once a day for 15 days in 20 Patients. |
| Intervention |
Trayodashang Guggulu, Sahacharadi Kwatha |
20 Patients will be treated by Trayodashang Guggulu 2 tab. (each tab. of 500 mg) after meals twice a day and Sahacharadi Kwatha 40ml Kwatha orally once empty stomach in morning for 30 days. |
| Intervention |
Trayodashang Guggulu, Sahacharadi Kwatha and Greeva Basti |
20 Patients will be treated by Trayodashang Guggulu 2 tab. (each tab. of 500 mg) after meals twice a day. Sahacharadi Kwatha 40ml Kwatha orally once empty stomach in morning for 30 days and Greeva Basti with Prasarini Taila daily for 45 min. once a day for 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to participate in trial.
2.The patients in the age group of 18 - 70 years of either sex.
3.The patients having clinical sign and symptoms of Greevasandhigata Vata w.s.r. to Cervical Spondylosis.
4.The patients having chronicity of disease less than 5 years.
5.The patients having radiological finding of Cervical Spondylosis.
|
|
| ExclusionCriteria |
| Details |
1.Recent cervical, spinal, or shoulder surgery or implanted instrumentation or previous surgery for cervical spondylotic myelopathy.
2.Patients with long term history of steroid and cytotoxic treatment.
3.Patients having concomitant illness like uncontrollable Hypertension, Diabetes Mellitus etc.
4.Patients with evidence of malignancy.
5.Patient participated in any clinical trial within last six months.
6.Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Shoola (pain) in patients suffering with Greevasandhigata Vata. |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Neck Disability Index. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
10/04/2021 |
| 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
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Cervical Spondylosis is a chronic degenerative
process of the cervical spine that affects the vertebral bodies and intervertebral
disks of the neck and may progress into disk herniation, bone spur formation,
compression of the spinal cord, or cervical spondylotic myelopathy.
Cervical Spondylosis is a degenerative joint disorder with the symptoms
of pain, restricted movements of the neck and joint instability. It is a slow
progressive disorder and occurs usually after the age of 40 years.
Cervical spondylosis is not explained details
in Ayurveda but condition can be managed using principle of Ayurveda.
The symptomatology of Sandhigata Vata
as described in Ayurveda classics is as follows- Hantisandhigatah
(loss of function), Shoola (pain), Aatopa. Vatapurnadriti Sparsha, Shotha, Prasarana Aakunchana
Savedana.
So Greevasandhigata Vata can be
correlated with Cervical Spondylosis due to similarity in the clinical
features.
As mentioned earlier it is
increasing health burden in present scenario. Various attempts have been made by many researchers to find out effective
solution for treatment of Cervical Spondylosis. The drugs used to treat Cervical Spondylosis in modern medical science have several side
effects and have chance of pain again after certain time of termination of
medication. The surgical treatment for Cervical Spondylosis is very costly and not a standard solution.
Many Ayurveda researcher have tried to find out solution of Cervical
Spondylosis treatment, but still could
not be established any standard effective guideline. So there is need to assess
the efficacy of drugs mentioned in Ayurveda classics and must be revalidated.
Aim:
To compare the efficacy of ‘Trayodashang Guggulu & Sahacharadi Kwatha’ with and without Greeva Basti in the management of ‘Greevasandhigata
Vata’ (Cervical Spondylosis).
Objectives:
To evaluate the clinical efficacy of ‘Trayodashang Guggulu & Sahacharadi Kwatha’ with and without Greeva Basti in the management of ‘Greevasandhigata
Vata’ (Cervical Spondylosis).
Null
hypothesis:
There is no difference between the effects of Trayodashang Guggulu & Sahacharadi
Kwatha’ with and without Greeva
Basti in
the management of Greevasandhigata Vata w.s.r. to Cervical Spondylosis.
Alternative
hypothesis:
There is significant difference between the
effects of Trayodashang Guggulu &
Sahacharadi Kwatha’ with and without Greeva
Basti in
the management of Greevasandhigata Vata w.s.r. to Cervical Spondylosis. |