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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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M489||Spondylopathy, unspecified. Ayurveda Condition: VATAJASULAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kaTibastiH, कटिबस्तिः (Procedure Reference: Caraka Samhita, Procedure details: Kati basti with Dashamoola Kwatha Route Topical Dose 400ml Frequency For 7days daily for 30 minutes)
2Comparator ArmProcedure-kaTibastiH, कटिबस्तिः (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 .

 
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