| CTRI Number |
CTRI/2022/05/042501 [Registered on: 12/05/2022] Trial Registered Prospectively |
| Last Modified On: |
07/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effectiveness of haridradi pinda sveda in the management of katigraha(low back pain) |
|
Scientific Title of Study
|
An open label clinical study of haridradi pinda sveda in the management of katigraha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjana Sujith |
| Designation |
Pg Scholar |
| Affiliation |
RGUHS |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9846263461 |
| Fax |
|
| Email |
anjanassujith@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr MURALIDHAR P PUJAR |
| Designation |
Professor |
| Affiliation |
RGUHS |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448033718 |
| Fax |
|
| Email |
drmuralidharpujar@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr MURALIDHAR P PUJAR |
| Designation |
Professor |
| Affiliation |
RGUHS |
| Address |
Department of Panchakarma
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9448033718 |
| Fax |
|
| Email |
drmuralidharpujar@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 573201 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital
BM Road Thanniruhalla Hassan 579201 |
| Type of Sponsor |
Private 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 Anjana Sujith |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
In patient Department of Panchakarma
BM Road Thanniruhalla Hassan 573201
Hassan
KARNATAKA |
9846263461
anjanassujith@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:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: katigraha, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: charaka samhitha, Procedure details: 30 patients of katigraha will be given svedana with haridradi pinda sveda for a period of 7 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who fulfil the diagnostic criteria
a. low back pain (kati shoola)
b. tenderness over lumbar region (sparshasahatva)
c.stiffness(stambha of kati pradesha)
d.restricted movements of spine(kriyahani)
Low back pain and tenderness over lumbar region is necessary diagnostic criteria that subjects must fulfill
2.Subjects between age group of 20 -60 years of age
3.Subjects fit for svedana karma
4.Subjects ready to give informed written consent form |
|
| ExclusionCriteria |
| Details |
1.Subjects having low backache due to infection, cancer, congenital causes
2.Diagnosed cases HIV,HBsAg,Tuberculosis
3.Pregnant and lactating mother
4.Fracture of hip joint |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Signs and symptoms of katigraha like katishoola assessed with oswestry low back pain score stambha with schober s test kriyahani with flexion and tenderness |
1st and 7 th day of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life |
Before and after treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/05/2022 |
| Date of Study Completion (India) |
09/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is an open label, single arm, prospective, clinical study to know the effectiveness of haridradi pinda sveda in the management of katigraha that will be conducted in India. The primary outcome will be oswestry low back pain score schober’s test flexion tenderness and that will be assessed at two intervals namely on 1st day second on 7th day |