| CTRI Number |
CTRI/2021/04/033017 [Registered on: 22/04/2021] Trial Registered Prospectively |
| Last Modified On: |
19/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO EVALUATE (CHECK) THE EFFICACY (EFFECTIVENESS) OF RAKTMOKSHAN (BLOOD LETTING) BY GHATI YANTRA (CUPPING INSTRUMENT) IN GRIDRASI (PAIN AND NUMBNESS RUNS DOWN IN ONE OR BOTH LEGS FROM THE LOWER BACK) W.S.R TO SCIATICA (PAIN AND NUMBNESS RUNS DOWN IN ONE OR BOTH LEGS FROM THE LOWER BACK) |
|
Scientific Title of Study
|
TO EVALUATE THE EFFICACY OF RAKTMOKSHAN BY GHATI YANTRA IN GRIDRASI W.S.R TO SCIATICA |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR RAJENDER SINGH |
| Designation |
READER |
| Affiliation |
SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, KURUKSHETRA |
| Address |
ROOM NO. 102, P.G. DEPARTMENT OF SHALYA TANTRA, SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, UMRI ROAD SECTOR-8, KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9416662761 |
| Fax |
|
| Email |
drrajendersingh1346@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SUPRIYA ARORA |
| Designation |
P.G. SCHOLAR |
| Affiliation |
SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, KURUKSHETRA |
| Address |
ROOM NO. 102, P.G. DEPARTMENT OF SHALYA TANTRA, SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, UMRI ROAD SECTOR-8, KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9872085651 |
| Fax |
|
| Email |
aroradrsupriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SUPRIYA ARORA |
| Designation |
P.G. SCHOLAR |
| Affiliation |
SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, KURUKSHETRA |
| Address |
ROOM NO. 102, P.G. DEPARTMENT OF SHALYA TANTRA, SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, UMRI ROAD SECTOR-8, KURUKSHETRA
Kurukshetra
HARYANA
136118
India |
| Phone |
9872085651 |
| Fax |
|
| Email |
aroradrsupriya@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, UMRI ROAD SECTOR-8, KURUKSHETRA 136118 |
|
|
Primary Sponsor
|
| Name |
SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL KURUKSHETRA |
| Address |
ROOM NO. 102, P.G. DEPARTMENT OF SHALYA TANTRA, SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, UMRI ROAD SECTOR-8, KURUKSHETRA 136118 |
| Type of Sponsor |
Other [SELF] |
|
|
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 RAJENDER SINGH |
SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, KURUKSHETRA |
ROOM NO. 102, P.G. DEPARTMENT OF SHALYA TANTRA, SHRI KRISHNA GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL, UMRI ROAD SECTOR-8, KURUKSHETRA
Kurukshetra
HARYANA |
9416662761
drrajendersingh1346@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:M472||Other spondylosis with radiculopathy. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
RAKTMOKSHAN |
RAKTMOKSHAN BY GHATI YANTRA
The affected gluteal region with maximum tenderness will be selected and will be disinfected with antiseptic solution.
3-4 pricks will be given on the skin of affected gluteal region with the help of needle which leads to pinpoint bleeding.
Then specific ghati yantra will be wiped out from inside with spirit gauze & heated with matchstick to create the vacuum, which will be then quickly placed on bleeding points.
Oozing of blood will occur and blood will be collected. Then the ghati yantra will be removed.
Haridra in powdered form will be applied on the site of pricking and dressing will be done with bandaging material. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. 30 Patients with sign & symptoms of Gridhrasi
2. Patients of either sex
3. Patients having an age group of 20-60 years.
4. Willingness of patients for study
5. Patients having SLR Positive between 30 to 70 degree. |
|
| ExclusionCriteria |
| Details |
1. Age below 20 years & above 60 years
2. Uncontrolled Diabetes mellitus, hypertension
3. Tuberculosis of spine & hip joint
4. Fracture related to the spine
5. Anaemia (haemoglobin <7.00mg/dl)
6. Pregnancy
7. Malignancy of spine
8. Herpes simplex infection causing radiating pain
9. Paralysis
10. Lumbar canal stenosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REDUCTION IN PAIN AND STIFFNESS |
FOLLOW UP WILL BE DONE EVERY 7TH DAY FOR 45 DAYS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| IMPROVEMENT AND INCREASE IN RANGE OF MOVEMENT OF THE AFFECTED LEG |
FOLLOW UP WILL BE DONE EVERY 7TH DAY FOR 45 DAYS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
26/04/2021 |
| 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
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Ayurveda, Gridhrasi is described as one of the vatvyadhi. The clinical manifestations include Ruja (Pain), Toda (Pricking), Stambha (Stiffness). On the basis of symptoms of Gridhrasi, it can be equated with the disease sciatica in modern science. Sciatica is characterized by severe pain radiating from the lower back leg caused by compression, irritation or inflammation of the sciatic nerve. Due to the increased incidence of this disease, it has been taken for study.
However in Gridhrasi,
as snayu and rakta are involved, Raktmokshan is a choice of treatment. Pain is the cardinal symptom in most of the vatavyadhis.
Gridhrasi is such a Ruja Pradhan vatavyadhi. Hence, Raktmokshan considered as
instant healers of pain. Patients having symptoms of Gridhrasi will be treated by Raktmokshan using a specific instrument called Ghati Yantra. Raktmokshan is considered to be the supreme as it drains out vitiated rakta & cures the disease. It will provide cost-effective treatment.
|