| CTRI Number |
CTRI/2020/03/024331 [Registered on: 27/03/2020] Trial Registered Prospectively |
| Last Modified On: |
22/01/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia
Other (Specify) [Raktamokshana] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Blood letting procedure in the disease of Sciatica |
|
Scientific Title of Study
|
Clinical Study of Raktamokshana Procedure in the Disease of Gridhrasi. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Padma Lochan Sankhua |
| Designation |
Reader in Panchakarma |
| Affiliation |
Goverment P. G. Ayurveda College and Hospital, Choukaghat, Varanasi |
| Address |
Govt. P. G. Ayurveda College and Hospital, Choukaghat, Varanasi. U.P.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9140258700 |
| Fax |
|
| Email |
pls_bls@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padma Lochan Sankhua |
| Designation |
Reader in Panchakarma |
| Affiliation |
Goverment P. G. Ayurveda College and Hospital, Choukaghat, Varanasi |
| Address |
Govt. P. G. Ayurveda College and Hospital, Choukaghat, Varanasi. U.P.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9140258700 |
| Fax |
|
| Email |
pls_bls@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padma Lochan Sankhua |
| Designation |
Reader in Panchakarma |
| Affiliation |
Goverment P. G. Ayurveda College and Hospital, Choukaghat, Varanasi |
| Address |
Govt. P. G. Ayurveda College and Hospital, Choukaghat, Varanasi. U.P.
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9140258700 |
| Fax |
|
| Email |
pls_bls@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Government P.G. Ayurveda College and Hospital, Varanasi |
|
|
Primary Sponsor
|
| Name |
Government PG Ayurveda College and HospitalVaranasi |
| Address |
Choukaghat, Varanasi, Uttar Pradesh,221002 |
| 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 Padma Lochan Sankhua |
Government P.G. Ayurveda College and Hospital, Varanasi |
Room number 8, Department of Panchakarma, Choukaghat, Varanasi
Varanasi
UTTAR PRADESH |
9140258700
pls_bls@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Government PG Ayurveda College and Hospital, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Raktamokshana |
50 ml of blood letting is done in two sittings in a gap of 1 week, first at below the medial malleolus of both the limbs and in next sitting at both the side of lumbar regions by Multiple Vacuum Syringe Blood Aspiration Procedure, time duration will be upto 2 hours and dressing of wound will be done for next 3 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
piercing pain, stiffness, distressand frequent quivering, starting from gluteal region, radiating to the lumbar region and back, moves downwards in the way of thigh, knees, calves and feet respectively. |
|
| ExclusionCriteria |
| Details |
01.Patients below 15 yrs age and above 70 yrs of
age.
02. Patients of any skin disease, heart disease
and diabetes mellitus.
03.Patients of both hypertension and
hypotension.
04. Patients of any fatal diseases.
05. Patients of Psychological disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, tingling sensation , stiffness and other signs and symptoms |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No recurrence of signs and symptoms |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2020 |
| Date of Study Completion (India) |
30/09/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2021 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Article-1 :- Published in IJRAP.
Topic:- Multiple Vacuum Syringe Blood Aspiration Procedure (MVSBAP): A New Horizon of Raktamokshana Procedure in Panchakarma Therapy of Ayurveda.
DOI: 10.7897/2277-4343.1206168
Article 2 :- Published in Journal of Ayurveda and Integrated Medical Sciences.
Topic:- Clinical Study of Raktamokshana Procedure in the disease Gridhrasi.
DOI: 10.21760/jaims.6.6.3 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Clinical Study Setting: Patient suffering from Gridhrasi will be selected from OPD and IPD of Government PG Ayurveda College and Hospital, Varanasi, 221002. 1) Inclusive Criteria: Patients between age group of 20 to 60 years, having both gender, having clinical features of Gridhrasi. 2) Exclusive criteria: Patients of any skin disease, heart disease, diabetes mellitus , Patients of both Hypertension and Hypotension , any congenital disease, psychological disorders. 3) Grouping: 60 patients will be randomly assigned in two groups. 4)Procedure: 50 ml of blood letting is done in two consecuative sittings , first from side of medial malleolus of bilateral lower limbs and followed by from both the sides of lumbar region after 15 days of the first sitting and dressing of wound is done for 3 consecuative days. 5)Follow up will be done on 15th day and 30th day. 6) Statistical method of analysis: The parameters of baseline data will be compared with the follow up status for assessment of results. All the result analysis will be done by using SPSS ver. 20 softer and obtained result will be interpreted statistically for "P" value. |