FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/01/011098 [Registered on: 02/01/2018] Trial Registered Retrospectively
Last Modified On: 29/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare Effect Of Two Basti (Medicated Enema)With Some Herbal Drug In The Management Of Sciatica 
Scientific Title of Study   A comparative clinical study on the effect of Ksheerbala Taila Matra Basti and Erandmooladi Yoga Basti followed by Rasna Guggulu in the management of Gridhrasi(Sciatica) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Gopesh Mangal 
Designation  Assistant proffesor 
Affiliation  National Institute of Ayurveda 
Address  I/C HOD P G Department of panchkarma National Institute of Ayurveda jorawar singh gate

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  Gmangal108@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopesh Mangal 
Designation  Assistant proffesor 
Affiliation  National Institute of Ayurveda 
Address  I/C HOD P G Department of panchkarma National Institute of Ayurveda jorawar singh gate

Jaipur
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  Gmangal108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr kapil sharma 
Designation  M D Scholar 
Affiliation  National Institute of Ayurveda 
Address  P G Department of panchkarma National Institute of Ayurveda jorawar singh gate

Jaipur
RAJASTHAN
302002
India 
Phone  9462201066  
Fax    
Email  sharma.kapil0608@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Madhav vilas palace Jorawar singh gate Amer road jaipur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr Gopesh mangal  P G Department of panchkarma national institute of Ayurveda jaipur 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gopesh mangal  National Institute Oof Ayurveda  department of panchakarma near jorawar singh gate madhav vilas jaipur
Jaipur
RAJASTHAN 
8619849011

Gmangal108@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Gridhrasi (Sciatica),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Panchasakar Churna with Erandmooladi Niruha Basti with Rasna Guggulu   Anulomana with Panchasakar Churana 5 grams for first two days followed by Erandmooladi Niruha Basti in Yoga Basti schedule (8 days)followed by Rasna Guggulu 1 gram (500mg each tablet)three times a day for 30days  
Intervention  Panchaskara churna with Ksheerbala Taila Matra Basti with Rasna Guggulu   Anulomana with Panchasakar Churana 5 grams for first two days followed by Matra Basti with Ksheerbala Taila for 8 days followed by Rasna Guggulu 1 gram (500mg each tablet) three times a day for 30days 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with Classical sign & symptoms of Gridhrasi and diagnosed cases of sciatica.
2. Sciatica due to lumber disc degenerative diseases.
3. Sciatica due to degenerative changes in the joints of lumbar Vertebrae.

 
 
ExclusionCriteria 
Details  1. Patients with severe renal and cardiac diseases.
2. Pregnant women
3. malignancy
4. Infectious conditions of spine
5. Patient who have lost the control on bowel and bladder.
 
 
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 
patients of either sex 16-70 yr old diagnosed with Gridhrasi (sciatica) will be selected for relief in sign and symptoms  70 days  
 
Secondary Outcome  
Outcome  TimePoints 
1 To assess the effect of Erandmooladi Yoga Basti & Rasna Guggulu in Gridhrasi (sciatica)
2 To assess the effect of Matra Basti with Ksheerbala Taila & Rasna Guggulu in Gridhrasi (sciatica)
3 To compare the efficacy between the Erandmooladi Yoga Basti and Matra Basti
 
70 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 
Date of First Enrollment (India)   10/10/2017 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Present day life style has created several health related problems; mainly musculo-skeletal disorders; One among them is sciatica and low back pain. Low back pain affects the quality of life particularly in most productive period of life. The incidence rate of this disease is significant as more than three quarters of the world’s population experience low back pain at some or other time during their life time. It is most common cause of sickness which results in absence from work. The person who suffers from this disease is partially handicapped, as the patient may not be able to walk, stand or sit comfortably.

Sciatica is very painful condition in which pain begins in lumber region and radiate along the postero lateral aspect of the thigh and leg. Based on sign and symptoms sciatica can be correlated with Gridhrasi in Ayurveda which is considered as Shool pradhan Vata vayadhi. The cardinal sign and symptoms of  Gridhrasi are Ruk(pain),Toda(pricking type of pain), Stambha (stiffness) and Muhu spanda (twitching) in the  Sphika, Kati,Uru, Janu,Jangha  and Pada in order and Sakhthishepa nigraha i.e. restricted lifting of the leg.

             In modern medicine mainly treatment is concerned about pain management or surgical correction of the pathology. In Ayurveda holistic treatment is explained. Basti is said to be superior treatment for Vata Vyadhi. More over in Chikitsa sutra of Gridhrasi, Basti is advised further Erandmooladi Basti is specifically advised in the symptoms complex similar to Gridhrasi.

 

 The reason for selection of this disease is because of its prevalence in the society and its effect on quality of life. In modern science if pain and neurological defects do not subside on prolonged conservative treatment, finally surgery is considered, which is not a right choice as it may leads to several complications like  permanent damage to the spinal cord / Nerves , loss of working capabilities on one side and on the other side it is an costly affairs. So there is need to find out safe, cost effective, long lasting and non invasive treatment.

          Basti is commonly advised for the treatment of Gridhrasi. The combination of Niruha and Anuvasana Basti is a costly affair and require hospitalization and strict code of conduct, on the other side Matra Basti is much safe, cost effective and devoid of code of conduct. Hence the present study is planned with following aims and objectives.


 
Close