| CTRI Number |
CTRI/2020/06/025544 [Registered on: 02/06/2020] Trial Registered Prospectively |
| Last Modified On: |
14/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of Agnikarma and siravyadha in sciatica. |
|
Scientific Title of Study
|
An Open Randomized Comparative Clinical Study of Agnikarma and Siravyadha in the management of Gridhrasi w.s.r. to Sciatica. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
prof Sanjeev Sharma |
| Designation |
Director |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG department of Shalyatantra, National Institute of Ayurveda jorawar singh gate, Amer road Jaipur,
Jaipur
RAJASTHAN
302002
India |
| Phone |
9418079691 |
| Fax |
|
| Email |
profsanjeevhp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Season koju |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of shalyatantra,National Institute of ayurveda,,Jorawar singh gate Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8173988769 |
| Fax |
|
| Email |
kojuseason977@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Season koju |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
PG Department of shalyatantra,National Institute of ayurveda,,Jorawar singh gate Amer road, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8173988769 |
| Fax |
|
| Email |
kojuseason977@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG department of shalyatantra, National Institute of Ayurveda. |
|
|
Primary Sponsor
|
| Name |
National institute of ayurveda |
| Address |
Madhav vilas palace,Amer road, Jaipur, Rajasthan, India |
| Type of Sponsor |
Other [Government Ayurveda Institute 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 |
| Season Koju |
National Institute of Ayurveda |
Amer road, Jaipur, 302002.
Jaipur
RAJASTHAN |
8173988769
kojuseason977@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M543||Sciatica, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnikarma |
1. keeping patient in suitable position, agnikarma with tamra shalaka after heating it to red hot will be done in bindu dagdha on the most tender spot .
2. seven bindu vrana will be made in a rosette pattern.
3. ghritkumari pulp will be applied over the vrana and gauze impregnated with madhuyasti churna will be kept and bandaged. |
| Comparator Agent |
Siravyadha |
keeping patient in suitable position, after snehana and svedana, siravyadha from great saphenous vein on anterio-superior surface of medial malleolus will be done by sterile disposable needle.50 ml blood will be let out in one sitting. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. patient pertaining features of sciatica.
2. patient with signs of sciatica.
3. sciatica due to disc prolapse.
sciatica due to grade I spondylolisthesis. |
|
| ExclusionCriteria |
| Details |
1. Patient with history or ongoing malignancy.
2. recent history of trauma, fracture of affected lower limb or spine.
3. congenital or acquired lower limb deformity.
4. patient with local infection or skin diseases at the proposed site of agnikarma or siravyadha.
5. patient suffering from Diabetes,cardiovascular disease ,HIV or major systemic diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in clinical manifestations of Sciatica |
After completion of the trail |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in quality of life (QoL) of patients.
2. Establishment of cost effective Ayurveda treatment modality in Sciatica. |
After completion of trail |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
22/06/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Gridhrasi can be correlated with sciatica in modern medical science. Sciatica is a lumbosacral radicular leg pain that follows dermatomal pattern affecting knee and feet and toes.
In this study, an ayurvedic interventional treatment modalities will be compared.
Group A (30Pts) - This group will be intervened with Agnikarma by Tamra Shalaka on the area of maximum tenderness. Group B (30Pts) - This group will be intervened with Siravyadha from great saphenous vein on anterio-superior aspect of medial malleolus. Three sittings for each intervention will be done at the interval of a week. |