| CTRI Number |
CTRI/2019/09/021248 [Registered on: 16/09/2019] Trial Registered Prospectively |
| Last Modified On: |
12/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A CLINICAL STUDY OF ASSESSMENT OF VATA DOSHA BY BLOOD LETTING THERAPY IN CASES OF SCIATICA (A DISEASE IN WHICH PAIN IS PRESENT FROM HIP REGION TO FOOT) |
|
Scientific Title of Study
|
A CLINICAL STUDY OF ANALYZING AND QUANTIFYING VATA DOSHA BY A DEVICE (BASED ON HRV TECHNOLOGY), BEFORE AND AFTER THE PROCEDURE OF SIRAVYADHA IN VATA VYADHI W.S.R. TO GRIDHRASI (SCIATICA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not registered with any other registry |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR PRADEEP G DESAI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI JAIN AGM AYURVEDIC MEDICAL COLLEGE AND HOSPITAL VARUR |
| Address |
NAVAGRAHA TEERTHA, VARUR-HUBLI - 581207 (KARNATAKA)
Dharwad
KARNATAKA
581207
India |
| Phone |
9916899558 |
| Fax |
|
| Email |
drpradeepsgd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJEEV GOVIND DOLE |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY, P.O. LIMDA, TQ: WAGHODIA, DIST: VADODARA
Vadodara
GUJARAT
391760
India |
| Phone |
9822563595 |
| Fax |
|
| Email |
rajeev.dole26827@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR PRADEEP G DESAI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI JAIN AGM AYURVEDIC MEDICAL COLLEGE AND HOSPITAL VARUR |
| Address |
NAVAGRAHA TEERTHA, VARUR-HUBLI - 581207 (KARNATAKA)
Dharwad
KARNATAKA
581207
India |
| Phone |
9916899558 |
| Fax |
|
| Email |
drpradeepsgd@gmail.com |
|
|
Source of Monetary or Material Support
|
| PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY, VADODARA, GUJARAT |
| SRI JAIN AGM AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, VARUR-HUBBALLI |
|
|
Primary Sponsor
|
| Name |
DR PRADEEP G DESAI |
| Address |
SRI JAIN AGM AYURVEDIC MEDICAL COLLEGE AND HOSPITAL, NAVAGRAHATEERTHA, VARUR-HUBBALLI - 581207 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PRADEEP G DESAI |
SANJEEVINI MULTISPECIALITY HOSPITAL AND RESEARCH CENTRE |
OPD No 2
Dharwad
KARNATAKA |
9916899558
drpradeepsgd@gmail.com |
| DR PRADEEP DESAI |
SRI JAIN AGM AYURVEDIC MEDICAL COLLEGE AND HOSPITAL |
OPD Department of Shalya Tantra
Dharwad
KARNATAKA |
9916899558
drpradeepsgd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECHR PARUL INSTITUTE OF AYURVEDA |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SIRAVYADHA PROCEDURE |
Readings by a HRV based device will be used before and after the procedure of Siravyadha in cases of Gridhrasi |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Pratyatma lakshanas of Gridhrasi and sakti utksepa nigahana.
Patients fit for Siravyadha.
Patients aged between 20-60yrs who fulfill the diagnostic criteria irrespective of the sex.
|
|
| ExclusionCriteria |
| Details |
Patients with evidence of congenital anomalies of the spine, Spinal tuberculosis, Neoplasm’s, Traumatic fracture, Epidural abscess and others will be excluded after proper clinical examination and investigation.
Patients with bleeding disorders.
Patients where surgical intervention is needed.
Patients with other systemic disorders like DM, Cardiac diseases, Renal failure, etc.
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantification and Qualitative analysis of Vata Dosha in terms of Graphs |
Analysis will be done Before and after the procedure of Siravyadha |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN SIGNS AND SYMPTOMS OF GRIDHRASI |
Assessment on 10th day after the procedure of Siravyadha |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
23/09/2019 |
| 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="0"
Months="6"
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
|
Shodhana
chikitsa is one of the most important treatment modality in ayurveda.
Siravyadha is one among the panchashodhana and it is considered
best among various treatment modalities explained for siravydha sadhya vyadhi.Basti
is regarded as the prime treatment modality among the panchakarma. It is invariably useful in diseases of rakta avruta
vata, pitta, kapha samsarga and sannipata condition of dosha.
Siravyadha is considered as the ardhachikitsa in Shalyatantra. Siravyadha
is a simple parasurgical procedure in which particular veins (sira) in the body
are punctured as per the disease condition and dooshita rakta is drained out.
Siravyadha is a cost effective and less time consuming procedure. Hence an
attempt is made to study the efficacy of this simple cost effective treatment
in Gridhrasi.
Assessing Vikruti - Dosha and
Subdosha balance, Agni Dhatu, balance of Pancha Mahabhuta, “Pulse of the
organs†helps forming recommendations for diet, herbal therapy,
aromatherapy and lifestyle. Here, in this study an attempt is made to
analyze and quantify Vata dosha in 80 subjects of Vata vyadhi w.s.r. to
Gridhrasi (Sciatica) before and after Siravyadha procedure. |