| CTRI Number |
CTRI/2018/10/016001 [Registered on: 12/10/2018] Trial Registered Prospectively |
| Last Modified On: |
29/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
AYURVEDIC MANAGEMENT OF NECK PAIN & STIFFNESS WITH "WARM MEDICATED OIL BATH" AND "MEDICATED PASTE" OVER NECK AREA. |
|
Scientific Title of Study
|
“Clinical study to compare the efficacy of Greeva Basti with Ashwagandhadya Taila and Lepan with Vajigandha Kalka in Greevastambha w.s.r. to Cervical Spondylosisâ€. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NEERAJ SONI |
| Designation |
P.G. SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
| Address |
PG DEPARTMENT OF PANCHKARMA, NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS, JORAWAR SINGH GATE, AMER ROAD, JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
9415179806 |
| Fax |
91-141-2635709 |
| Email |
dr.soni.neeraj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GOPESH MANGAL |
| Designation |
ASSSIATANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
| Address |
PG DEPARTMENT OF PANCHKARMA, NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS, JORAWAR SINGH GATE, AMER ROAD, JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
91-141-2635709 |
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR GOPESH MANGAL |
| Designation |
ASSSIATANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
| Address |
PG DEPARTMENT OF PANCHKARMA, NATIONAL INSTITUTE OF AYURVEDA, MADHAV VILAS, JORAWAR SINGH GATE, AMER ROAD, JAIPUR
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
91-141-2635709 |
| Email |
gmangal108@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda Madhav Vilas Palace Amer Road Jorawar singh Gate Jaipur
302002 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda |
| Address |
National Institute Of Ayurveda Madhav Vilas Palace Amer Road
Jorawarsingh Gate Jaipur 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 GOPESH MANGAL |
National Institute Of Ayurveda |
National Institute Of Ayurveda Madhav Vilas Palace Amer Road
Jorawar singh Gate Jaipur 302002
Jaipur
RAJASTHAN |
8619849011
gmangal108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, NIA, JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M479||Spondylosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Greeva basti |
Greeva basti with Ashwagandhadya taila for a period of 45 minutes and duration of 14 consecutive days. |
| Intervention |
Greeva Lepan |
Lepan with Vajigandha kalka after mridu Abhgyanga with Sarsap taila, for a period of 45 minutes and duration of 14 consecutive days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from classical signs and
symptoms of Greeva stambha vis-a-vis cervical
spondylosis.
2. Patients irrespective of sex, religion and
socio-economic status.
3. Patient willing and able to participate in
the study for 14 days.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from any acute diseases/
infectious diseases/metabolic
diseases/chronic diseases (like rheumatoid
Arthritis, DM, Gout, TB, SLE, Ankylosing
spondylitis etc.)
2. Patients with major systemic disorders that
may interfere with the course of treatment.
3. Stenosis of Spinal Canal, Myelopathy.
4. Pregnant ladies and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in Subjective and objective parameters.
|
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find the comparative efficacy of either
treatment. |
30th day. |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
15/10/2018 |
| Date of Study Completion (India) |
13/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Conclusion can be made from the present study that the symptomatic improvement in two groups, Group-A (Greeva Basti) show Mild to Good improvement, while Group-B (Greeva Lepan) showed Mild to Moderate improvement in management of Greevastambha. On follow-up, relief was sustained for longer period in Group-A, as compared to Group-B. Out
of 15 patients in Greeva Basti Group
(Group A) out of 15 patients, 07 (46.67%) patients showed moderate improvement,
08 (53.33%) patient showed good improvement in all symptoms after Treatment. No
patient remained unchanged and no patient felt Excellent improvement in
Group-A. After
the Follow up 02 (13.33%) patients showed mild improvement, 11 (73.33%) patients
showed moderate improvement and 02 (13.33%) patients felt good improvement.
In
Group B out of 15 patients, 12 (80.00%) patients showed moderate improvement,
03 (20%) patients showed good improvement after Treatment.
After
the Follow up 05 (33.33%) patients showed mild improvement, 10 (66.66%) patients
showed moderate improvement. From this data finally, we can
conclude that Greeva Basti with Ashwagandhadya
Taila is comparatively more
effective and relief sustained for longer period as compared with Greeva
Lepan with Vajigandha Kalka but both modalities are effective in management of Greevastambha (Cervical Spondylosis) as
these are safe, cost effective and free from any adverse effects. |