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CTRI Number  CTRI/2024/10/075565 [Registered on: 21/10/2024] Trial Registered Prospectively
Last Modified On: 21/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative Study of Tikta Ksheera Basti and Lashuna Ksheera Basti for Managing Sciatica: Evaluating Efficacy and Impact on Inflammatory Marker 
Scientific Title of Study   Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Tikta Ksheera Basti And Lashuna Ksheera Basti In The Management Of Gridrasi (Sciatica) And Its Influence On Inflammatory Marker 
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 Shailesh 
Designation  PhD Scholar in Ayurveda 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Dept Of Panchakarma Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan

Hassan
KARNATAKA
573201
India 
Phone  7795840838  
Fax    
Email  shettyshailesh9@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr LOHITH B A 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department Of Panchakarma, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan KARNATAKA

Hassan
KARNATAKA
573201
India 
Phone  9886749168  
Fax    
Email  drlohithpk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr LOHITH B A 
Designation  Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital 
Address  Department Of Panchakarma, Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan KARNATAKA

Hassan
KARNATAKA
573201
India 
Phone  9886749168  
Fax    
Email  drlohithpk@gmail.com  
 
Source of Monetary or Material Support  
Self and Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla, Hassan- 573201 
 
Primary Sponsor  
Name  Dr Shailesh 
Address  Associate Professor Department of Panchakarma Dr N A Magadum Ayurvedic Medical College Hospital and Research Centre Ankali 591213 Belagavi Karnataka 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shailesh  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  OPD Number 5, Department of Panchakarma
Hassan
KARNATAKA 		 7795840838

shettyshailesh9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M544||Lumbago with sciatica. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka Samhita Siddhi Sthana Chapter 3 Sutra 17 to 20, Procedure details: Anuvasana Basti will be given on the first day followed by Tikta Ksheera Basti in the morning & anuvasana basti in the afternoon for next 6 days, on 8th & 9th day Anuvasana basti will be given after food, C-reactive protein will be assessed before the treatment & during follow up )
(1) Medicine Name: Tikta Ksheera Basti, Reference: Charaka Samhita, Sutrasthana. Ch. 28, Sutra. 27, Route: Rectal, Dosage Form: Not Applicable, Dose: 570(ml), Frequency: od, Duration: 6 Days
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charaka Samhita Siddhi Sthana Chapter 3 Sutra 17 to 20, Procedure details: Anuvasana Basti will be given on the first day followed by Lashuna Ksheera Basti in the morning & anuvasana basti in the afternoon for next 6 days on 8th & 9th day Anuvasana basti will be given after food C-reactive protein will be assessed before the treatment & during follow up)
(1) Medicine Name: Lashuna Ksheera Basti, Reference: Charaka samhita, Chikitsa sthana,Chapter 5, Sutra 95, Route: Rectal, Dosage Form: Not Applicable, Dose: 570(ml), Frequency: od, Duration: 6 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Having the complaints less than 1 year
2. Patients of either Gender, above 20 years Below 60 years
3. The patients, who are fit for Basti.
4. Patients who are ready to participate and have signed informed consent form. 
 
ExclusionCriteria 
Details  1. Benign or malignant tumor of the spine
2. Tuberculosis of the vertebral column
3. Uncontrolled diabetes mellitus
4. Cardiovascular disease
5. Pregnancy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Ruk (Throbbing Pain) Reduction
2.Toda (Pricking Pain) Reduction
3.Stamba (Stiffness) Reduction
4.Gourva (Heaviness) Reduction
5.Samyak Niruha and Anuvasana Basti Lakshanas
 		 18 Days 
 
Secondary Outcome  
Outcome  TimePoints 
1. Visual analogue scale
2. Bragards sign
3. Straight leg raising test active
4. Coin test
5. Gait
6. Standing time
7. Walking time
8. Oswestry Low Back Disability Questionnaire
 		 18 Days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   01/04/2025 
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="6"
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  

Study Summary: Randomized Controlled Clinical Trial on Tikta Ksheera Basti and Lashuna Ksheera Basti in the Management of Gridhrasi (Sciatica) and its Influence on Inflammatory Markers

Background:
Gridhrasi (Sciatica), a condition characterized by pain radiating from the lower back to the legs, is one of the most common health issues affecting both physical and mental well-being. This study compares two Ayurvedic treatments—Tikta Ksheera Basti and Lashuna Ksheera Basti—both used in managing Vata-related disorders, specifically targeting Gridhrasi. Lashuna (garlic) is known for its anti-inflammatory, antioxidant, and neuroprotective properties, while Tikta Ksheera (medicated milk) is a traditional remedy for Vata disorders. This study seeks to evaluate their effectiveness in alleviating symptoms and their influence on inflammatory markers, particularly C-reactive protein (CRP).

Research Objectives:

  1. To evaluate the effectiveness of Lashuna Ksheera Basti in managing Gridhrasi.
  2. To assess the influence of Lashuna Ksheera Basti and Tikta Ksheera Basti on inflammatory markers like CRP.
  3. To compare the effects of Lashuna Ksheera Basti and Tikta Ksheera Basti in reducing the symptoms of Gridhrasi.
  4. To identify a more effective and economical treatment for Gridhrasi.

Research Questions:

  1. Is there a significant difference in the effects of Lashuna Ksheera Basti and Tikta Ksheera Basti in managing Gridhrasi?
  2. Is there a significant difference in their influence on CRP levels?

Methodology:

  • Study Population: 100 patients diagnosed with Gridhrasi (sciatica) will be randomly assigned into two groups of 50 each.
  • Group A: Will receive Tikta Ksheera Basti treatment.
  • Group B: Will receive Lashuna Ksheera Basti treatment.

Both groups will receive Niruha Basti followed by Anuvasana Basti (oil enema) as per modified Kala Basti Schedule, on the first and last two days of the 9-day treatment regimen both groups will receive only anuvasana basti. CRP levels will be measured before and after treatment.

Inclusion Criteria:

  1. Patients aged 20-60 with symptoms of Gridhrasi for less than 1 year.
  2. Fit for Basti treatment and willing to provide informed consent.

Exclusion Criteria:

  1. Patients with malignant spinal tumors, tuberculosis, uncontrolled diabetes, cardiovascular disease, or pregnancy.

Outcome Measures:

  • Primary Outcomes: Improvement in pain (Ruk), pricking sensation (Toda), stiffness (Stambha), heaviness (Gourva), and effectiveness of Basti (Samyak Niruha and Anuvasana Lakshanas).
  • Secondary Outcomes: Assessed through clinical signs like Bragard’s sign, the Straight Leg Raising test, and patient-reported measures like walking time, standing time, gait, and Oswestry Low Back Disability Questionnaire.

Laboratory Investigations:
CRP will be tested before and after treatment to assess the anti-inflammatory effects.

Duration of Study:

  • Treatment: 9 days
  • Follow-up: 18 days
  • Total: 28 days

Statistical Analysis:
Data will be analyzed using SPSS version 21. Parametric and non-parametric tests (t-tests, ANOVA, Mann-Whitney U test, Wilcoxon signed-rank test) will be used to evaluate treatment outcomes, with a significance level set at p < 0.05.

Conclusion:
This study aims to determine whether Lashuna Ksheera Basti is more effective and economical compared to Tikta Ksheera Basti in managing Gridhrasi, particularly in reducing inflammation and pain. 
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