| CTRI Number |
CTRI/2021/04/033192 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
24/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Cupping Therapy and Vatari Guggulu in Lumber Spondylosis (Kati-Sandhighat Vata). |
|
Scientific Title of Study
|
A comparative clinical study on raktamokshana(by modified shringa yantra) and vatari guggulu in the management of kati-sandhigata vata w.s.r to lumber spondylosis. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pankaj Hatela |
| Designation |
M.S.Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
PG dept. of Shalya Tantra, Madan Mohan Malviya Govt. Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
7412840543 |
| Fax |
|
| Email |
pankajhatela1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
prof Harimohan Meena |
| Designation |
Professor |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
PG dept. of Shalya Tantra, Madan Mohan Malviya Govt. Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9782166260 |
| Fax |
|
| Email |
dr_harimohan@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Hatela |
| Designation |
M.S. Scholar |
| Affiliation |
Madan Mohan Malviya Govt. Ayurved College Udaipur |
| Address |
PG dept. of Shalya Tantra, Madan Mohan Malviya Govt. Ayurved College Udaipur Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
7412840543 |
| Fax |
|
| Email |
pankajhatela1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt. Ayurveda College, Udaipur |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurveda college Udaipur |
| Address |
Madan Mohan Malviya Government Ayurveda college Udaipur 313001 |
| 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 |
| Prof Harimohan Meena |
Madan Mohan Malviya Government Ayurveda college Udaipur |
Opd room No. 1, PG dept. Of Shalya Tantra, College
Hosp.,Madan Mohan Malviya Government Ayurveda college Udaipur.
Udaipur
RAJASTHAN |
9782166260
dr_harimohan@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Madan Mohan Malviya Government Ayurveda college Udaipur. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: KATISANDHIGATA VATA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CUPPING THERAPY(MODIFIED SHRINGA YANTRA) |
Minimum 15 Patients of
clinically diagnosed Kati
Sandhigata Vata (lumber
Spondylosis) will be treated with
Raktamokshan by modified
shringa yantra (cupping therapy)on (external skin)most tender area for 4 sitting at 7 days. interval. |
| Comparator Agent |
Vatari guggulu |
Minimum 15 Patients of
clinically diagnosed Kati
Sandhigata Vata (lumber
Spondylosis) will be treated with orak use of vatari guggulu 2 tablets (each tablate 250 mg) twice a day with lukewarm water for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient suffering from kati-sandhighat vata(lumber spondylosis) irrespective to demographic area.
patient between age group 30-70 years of both sex.
|
|
| ExclusionCriteria |
| Details |
1. Patients of uncontrolled diabetes mellitus, R.A. (Rheumatoid arthritis) positive.
2. Other diseases like paralysis, Parkinson’s disease, severe anemia, malignancy.
3. Patients below 30 years and above 70 years.
4. Pregnancy
6. Heart disease(IHD,CCF) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE CRITERIA:
1.KatiShoola (pain in lumbar area with visual analogue scale).
2. Kati Stambha (stiffness of lumbar joint)
3.Akunchan Prasarane Pravrutti Savedana (painfull joint on locomotion)
OBJECTIVE CRITERIA:
Assessment will be done on the basis of radiological findings before and after
treatment.
1. Range of movement (ROM).
2. X-ray of lumbar spine (KAL Scale).
3. ODI (Oswestry disability index) Scale
4. Schober’s Test |
SIX WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. acceptability/tolerance of treatment.
2. time to return to normal work life. |
6 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
03/05/2021 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is the comparative clinical trial, to study the etio-pathogenesis of Kati-Sandhigatavata (Lumber spondylosis) in both Ayurvedic and modern parlance and to evaluate the clinical efficacy of Rakatmokshna and Vatari Guggulu in Kati-SandhigataVata in light of both Ayurveda and modern and to evaluate the effect of cupping therapy and understand its mechanism of action in light of both Ayurveda and modern. In one group 15 patients of Kati-SandhigataVata (Lumbar Spondylosis) will be treated with Raktamokshan and in the another group of 15 Patients of Kati-SandhigataVata (lumber Spondylosis) will be treated with Vatari Guggulu. |