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CTRI Number  CTRI/2018/05/014210 [Registered on: 29/05/2018] Trial Registered Retrospectively
Last Modified On: 03/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurveda treatment for low back pain and pain radiating to leg 
Scientific Title of Study   EFFECTIVENESS OF SWEDANAM (AN AYURVEDIC TREATMENT MODALITY) IN DISC-RELATED SCIATICA: A PILOT CLINICALTRIAL 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  K AMBIKA 
Designation  Associate Professor  
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Kayachikitsa, Govt. Ayurveda College, Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9847457084  
Fax    
Email  ambikachitharanjan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V C Induleka 
Designation  Assistant professor 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Dravyaguna OPD No. 1, Room no.1, Main block Government Ayurveda College Hospital Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9446553068  
Fax    
Email  indudeepu78@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr V C Induleka 
Designation  Assistant professor 
Affiliation  Government Ayurveda College, Thiruvananthapuram 
Address  Department of Dravyaguna, OPD No. 1, Room no.1, Main block Government Ayurveda College Hospital Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9446553068  
Fax    
Email  indudeepu78@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurveda college, Thiruvananthauram, Department of Ayush, Government of Kerala 
 
Primary Sponsor  
Name  Principal Government Ayurveda College 
Address  Government Ayurveda college, Thiruvananthauram, Department of Ayush, Government of Kerala 
Type of Sponsor  Government funding agency 
 
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 Indulekha  Government Ayurveda College Hospital  Department of Dravyaguna, Department of Kayachikitsa, OPD No. 1, 2, Room no.1, 2, Main block
Thiruvananthapuram
KERALA 		 9446553068

indudeepu78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Government Ayurveda College, Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M472||Other spondylosis with radiculopathy, pain radiating from the lower back or buttock into the leg ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayurveda treatment modality  Patients of both Group A and Group B were internally given amapachana kashayam for seven days, and mriduvirechanam with 20 ml Erandathailam for one day, then swedana for 7-14 days 
Comparator Agent  conventional ayurveda treatment  Group B was applied with murivenna pichu and simple bandage with cotton cloth at night for 7-14 days 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  diagnosed with moderate to severe sciatica, according to the M-JOA criteria (> 10 score)  
 
ExclusionCriteria 
Details  Participants were excluded
if they suffer from serious life-threatening disease,
major heart disease
stroke
blood vessel disease such as deep vein thrombosis
major liver disorders like cirrhosis
major kidney disorders like nephropathy
psychotic patients.
Participants will not be eligible if they are female and whether pregnant or lactating.
The patients complicated with lumbar spinal canal stenosis and space-occupying lesions
complicated with lumbar spine tumors,
Infections
Tuberculosis
Who do not sign informed consent. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
M-JOA scale; known as the modified edition of JOA Back Pain Evaluation Questionnaire (Chen et al., 2011; Fukui et al., 2007), visual analogue scale for pain(Wewers and Lowe, 1990) and Maine-Seattle Back Questionnaire was used for the assessment of back specific functional status (Atlas et al., 2003; Grøvle et al., 2008).   base line and one month 
 
Secondary Outcome  
Outcome  TimePoints 
Maine-Seattle Back Questionnaire was used for the assessment of back specific functional status (Atlas et al., 2003; Grøvle et al., 2008).   base line, one month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1/ Phase 2 
Date of First Enrollment (India)   05/06/2017 
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="3"
Months="6"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 In the literature, ‘sciatica’ is an established term for pain radiating from the lower back or buttock into the leg.(Konstantinou and Dunn, 2008). Sciatica is a common symptom that affects as many as 40% of the adult population at some time. However, clinically significant sciatica is much less common and occurs in only 4% to 6% of the population (Frymoyer, 1991)and  prevalence ranged from 1.2% to 43%(Konstantinou and Dunn, 2008). Recently, a large number of patients with low back pain are turning to complementary and alternative treatments (Ernst and Chrubasik; Tekur et al., 2008). Still no strong evidence exists or no trial has yet evaluated the effectiveness of behavioural treatment and multidisciplinary treatment programmes.

Aim and Objective

The aim of this study is to investigate the effectiveness of valuakasweda and upanaha sweda compared with conventional treatment modalities in patients with sciatica.

Outcome

Assessment of pain and related problems of sciatica was done with M-JOA scale; known as the modified edition of JOA Back Pain Evaluation Questionnaire (Chen et al., 2011; Fukui et al., 2007), visual analogue scale for pain(Wewers and Lowe, 1990) and  Maine-Seattle Back Questionnaire  was used for the assessment of back specific functional status  (Atlas et al., 2003; Grøvle et al., 2008).    According to these criteria, a patient with sciatica was assessed including pain, the activities of daily life and work, function impairment, and special exams.  Therapeutic effect is assessed by comparing baseline and final conditions reported by the patient. This trial also recorded adverse effects reported by patients during treatment. 

 
 
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