| CTRI Number |
CTRI/2024/09/073523 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Ayurveda in lowback pain |
|
Scientific Title of Study
|
Efficacy Of Dashmoola Kwath Kati Basti In The Management Of Katigraha (w.s.r. To Non Specific Low Back Pain) – A Randomized Controlled Clinical Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreya Nikam |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
OPD no 04, IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
9168926535 |
| Fax |
|
| Email |
shreyanikam25@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
OPD no 04, IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
Belgaum KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajashekhar V Sanapeti |
| Designation |
Professor |
| Affiliation |
KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya |
| Address |
OPD no 04, IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi
KARNATAKA 590003 India |
| Phone |
9611442881 |
| Fax |
|
| Email |
rajashekharpk@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Nikam |
| Address |
OPD no 04, IPD Department of Panchakarma KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi 590003 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreya Nikam |
KLE Ayurveda Hospital and Medical Research Centre |
OPD no 04, IPD Department of Panchakarma KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi 590003 Belgaum KARNATAKA |
9168926535
shreyanikam25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee for Research on Human Subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya & KLE Ayurveda Hospital Shahapur Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M489||Spondylopathy, unspecified. Ayurveda Condition: VATAJASULAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Caraka Samhita, Procedure details: Kati basti with Dashamoola Kwatha
Route Topical
Dose 400ml
Frequency For 7days daily for 30 minutes)
| | 2 | Comparator Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: , Procedure details: Kati basti with Dashamoola Taila
Route Topical
Dose 400ml
Frequency For 7days daily for 30 minutes)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with signs and symptoms of katigraha ( Non-specific low back pain )
2 VAS Scale – 3-8
|
|
| ExclusionCriteria |
| Details |
1 Patients with a recent history of Spinal Surgery .
2 Patients with established Tumors /Malignancy .
3 Patients with diagnosed T.B. of bone .
4 Pregnant and lactating mother .
5 Patients suffering from Skin Allergy and Open Wounds at lumbar region .
6 Patients with active inflammation at lumbar region .
7 Patients with Sciatica
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Stiffness, VAS Scale, Oswetry low back pain disability questionnaires, Schobers Test |
0th day , 7th day & 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/10/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Concern for Golbal Healthcare: Low back pain (LBP) is a global healthcare concern
causing more global disability than any other medical condition. Katigraha
(Non-specific low back pain) is an important clinical, social, economic and
public health problem affecting the population worldwide.1
Early
Degeneration: The faulty dietary habits, extremes of sedentary life style,
wrong sitting posture, continuous sitting work are making the body prone to
early degeneration nowadays.
High Prevalance:
Low back pain is estimated at 60% to 70% in industrialized countries (one-year
prevalence 15% to 45%, adult incidence 5% per year).2 Age-standardized prevalance of Non Specific Low Back Pain is higher in
females than males.
Enhance quality of life: The fundamental purpose of the research is to
enhance life quality.
Through
the application of medicated oils and warm herbal preparations, Kati Basti
effectively targets the lower back muscles, ligaments and joints, thereby
reducing stress, stiffness and inflammation by enhancing circulation,
encouraging tissue healing and
re-establishing the balance of Vata
dosha which is frequently associated with musculoskeletal diseases based on
Ayurvedic principles .
Its importance as a beneficial
therapeutic intervention for people with low back pain is highlighted by its
non-invasive nature and capacity to offer both short-term and long-term relief. Administrating Kwath Kati Basti may help
in reducing symptoms of Katigraha similar to that in Taila Kati Basti.
Dashmoola
Kwath Kati Basti aims to alleviate exacerbated Vata and Kapha dosha, the
Ayurvedic principles associated with movement. Kwath Kati Basti also nourishes
and regenerates tissues, increasing general healing and flexibility.
The
herbal infusion penetrates deeply into the lower back muscles, ligaments, and
joints, increasing circulation and reducing pain and stiffness which is easy to
prepare without compromising its medicinal qualities .
High Quality Studies Inavailability:
There is lack of high-quality studies in the field of Kwath Kati Basti.
Hence
good quality clinical research is required to prove its therapeutic advantages
and understand its mechanism of action.
Cost Effectiveness: Dashmoola
Kwath Kati Basti will be less expensive than Dashmoola Taila Kati Basti.
Effectiveness
of Kwath Kati Basti over Taila Kati Basti:
The
purpose of this study is to compare the effects of Dashmoola Kwath Kati Basti
application over Dashmoola Taila Kati Basti, on Pain Severity, Physical
Function, Trunk ROM, and Quality Of Life in people with non-specific low back
pain . |