| CTRI Number |
CTRI/2024/11/076253 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Raktamokshan(blood letting) by Cupping in the management of Lumbar Spondylosis. |
|
Scientific Title of Study
|
A controlled clinical study to assess the effect of Raktamokshana on Pain and Mobility in Kati Sandhigata Vata w.s.r. to Lumbar Spondylosis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tanveer Shaikh |
| Designation |
PhD Scholar |
| Affiliation |
R. A. Podar Medical college (Ayu) |
| Address |
Department of Shalyatantra, First floor.
R. A. Podar Medical College (Ayu), Dr. Annie Besant Road, Worli, Mumbai, 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9579445038 |
| Fax |
|
| Email |
tanveershaikh85@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Rajeshwar Reddy |
| Designation |
PhD Guide |
| Affiliation |
R. A. Podar Medical college (Ayu) |
| Address |
Department of Shalyatantra, First floor,
R. A. Podar Medical College (Ayu), Dr. Annie Besant Road, Worli, Mumbai, 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9820864287 |
| Fax |
|
| Email |
reddyrajeshwar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanveer Shaikh |
| Designation |
PhD Scholar |
| Affiliation |
R. A. Podar Medical college (Ayu) |
| Address |
Department of Shalyatantra, 1st floor, Hospital Building,
R. A. Podar Medical College (Ayu), Dr. Annie Besant Road, Worli, Mumbai, 400018
Mumbai (Suburban)
MAHARASHTRA
400018
India |
| Phone |
9579445038 |
| Fax |
|
| Email |
tanveershaikh85@gmail.com |
|
|
Source of Monetary or Material Support
|
| M. A. Podar Hospital
R. A. Podar Medical College (Ayu), Worli, Mumbai |
|
|
Primary Sponsor
|
| Name |
Tanveer Shaikh |
| Address |
R. A. Podar Medical College (Ayu), Dr. Annie Besant Road, Worli, Mumbai, 400018 |
| Type of Sponsor |
Other [Research Scholar Himself] |
|
|
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 Tanveer Shaikh |
R A Podar Medical College |
Ward number 4,
Department of Shalyatantra, 1st floor, Hospital Building
Dr. Annie Besant road, Worli, Mumbai, 400018
Mumbai
MAHARASHTRA |
9579445038
tanveershaikh85@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC R A Podar Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | raktamokShaNam/ SoNitasrAvaH/ asravisrutiH/ SastravisrAvaNam, रकà¥à¤¤à¤®à¥‹à¤•à¥à¤·à¤£à¤®à¥/ शोणितसà¥à¤°à¤¾à¤µà¤ƒ/ असà¥à¤°à¤µà¤¿à¤¸à¥à¤°à¥à¤¤à¤¿à¤ƒ/शसà¥à¤¤à¥à¤°à | (Procedure Reference: Sushruta Sutrasthana 14, Procedure details: A minimum of 50 patients of Lumbar Spondylosis will be
randomly selected in both Trial group (Group A) & Control group
(Group B) based on the inclusion & exclusion criteria. 50 patients in Group A will be treated with 4 sessions of ‘Raktamokshan’
by ‘Hijama Cupping’. The interval between the sessions will be 7 days.)
| | 2 | Comparator Arm (Non Ayurveda) | | - | Group B | |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Selected on the basis of following signs and symptoms- Shula, Katistambha, Akunchan Prasarane Pavrutti savedana |
|
| ExclusionCriteria |
| Details |
Cancer, Pregnancy, TB, Diabetes Mellitus, HIV, HBsAg, Bleeding disorders, Anaemia, Fractured vertebrae |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Parameters- Pain and Mobility. Tests used will be VAS, Tenderness grade, Schobers test, SLRT |
Study period 3 months, follow up 1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Pain & increase in Mobility |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
26/11/2024 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Lumbar Spondylosis is the frequent culprit behind low back pain.
The phrase "Spondylosis of the lumbar spine" means degenerative changes
such as osteoarthritis of the vertebral joints and degenerating intervertebral
discs (degenerative disc disease) in the low back. The prevalence of Lumbar
Spondylosis is found to be between 38% to 85% in previous studies. In
United Kingdom alone, eight crore working days are lost every year due to
lumbar spondylosis. Hijama Cupping is a very effective, economical, reliable,
convenient and safe method for Raktamokshan. Can be modified
according to Dosha involved. Acts deep enough for desired effect (Field
of Action of Shrunga is 10 & that of tumbi is 12 angul)[2]. Has dual
advantage of suction & Raktamokshan.
This study plans to evaluate the efficacy of ‘Raktamokshan’ by
‘Hijama Cupping’ in comparison with ‘Diclofenac sodium + Linseed oil + Menthol +
Methyl Salicylate oint’ in the management of ‘Lumbar Spondylosis.’ |