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CTRI Number  CTRI/2023/11/059862 [Registered on: 15/11/2023] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study to Evaluate The Efficacy of Yuktaratha Yoga Basti in Sciatica.  
Scientific Title of Study   An Open Randomised Controlled Study to Evaluate The Efficacy of Yuktaratha Yoga Basti in Gridhrasi with special reference to Sciatica".  
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 Sachin Govindrao Tike 
Designation  Assistant Professor 
Affiliation  LRP Ayurvedic college and research centre urun Islampur 
Address  OPD No. 8, Panchakarma OPD Department of Panchakarma, Ground Floor, LRP Ayurvedic college and research centre urun Islampur, District- Sangli. Sangli MAHARASHTRA 415409 India

Sangli
MAHARASHTRA
415409
India 
Phone  9975014306  
Fax    
Email  ayur.drsachin@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Kumar Parida 
Designation  Professor 
Affiliation  LRP Ayurvedic college and research centre urun Islampur 
Address  LRP Ayurvedic college and research centre urun Islampur District Sangli Sangli MAHARASHTRA 415409 India

Sangli
MAHARASHTRA
415409
India 
Phone  9730245036  
Fax    
Email  dpkparida@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Kumar Parida 
Designation  Professor 
Affiliation  LRP Ayurvedic college and research centre urun Islampur 
Address  LRP Ayurvedic college and research centre urun Islampur District Sangli Sangli MAHARASHTRA 415409 India

Sangli
MAHARASHTRA
415409
India 
Phone  9730245036  
Fax    
Email  dpkparida@yahoo.co.in  
 
Source of Monetary or Material Support  
Government Ayurvedic Hospital Osmanabad, Dist- Osmanabad, Maharashtra Affiliated To Government Ayurvedic College,Osmanabad,Dist-Osmanabad, Maharashtra. 
 
Primary Sponsor  
Name  Dr Sachin Govindrao Tike 
Address  Loknete Rajarambapu Patil Ayurvedic College, Islampur,415409 District Sangli, Maharashtra 
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 Sachin Govindrao Tike  Government Ayurvedic College,Osmanabad  Panchakarma O.P.D. No 14, Ground Floor, Government Ayurvedic College,Osmanabad,413501 Maharashtra,India
Osmanabad
MAHARASHTRA 		 9975014306

ayur.drsachin@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTTEE,Govt. of Maharashtra,office of the Dean,Govt.Ayurvedic College,Tuljapur Road,Osmanabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-siddha-bastiH, सिद्ध-बस्तिः (Procedure Reference: Ch.Si.3/12, Procedure details: As per Yoga Basti schedule 8 Bastis-5 Anuvasan Basti with Murchita tila taila 75 ml and 3 Niruha yuktarath basti 570 ml will be given. Purvakarma-Sthanik Abhyang with Murchit Tila Taila and Nadi Sveda will be done on the lower abdomen, back and both the legs till samyak sved lakshnas. Pradhana Karma: Patient will be asked to lie in the left lateral position by keeping left leg straight and right leg flexed at the knee joint. Also the left hand should be kept folded behind the head, without the a)
(1) Medicine Name: Madhu – 100ml Saindhava – Lavana 10 gms Sneha Dravya – Murchita TilaTaila 120 ml Kalka Drvya – Yashtimadhu + Pippali 40 gms Kashaya – Brihat Panchmoola 300 ml Total –570 ml, Reference: Sh.Sa.U.6/33, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 570(ml), Frequency: od, Duration: 8 Days
2Intervention ArmProcedure-yuktaratha-bastiH, युक्तरथ-बस्तिः Pradhan Karma(Procedure Reference: Ch.Si.3/12, Procedure details: As per Yoga Basti schedule 8 Bastis-5 Anuvasan Basti with Murchita tila taila 75 ml and 3 Niruha yuktarath basti 570 ml will be given. Purvakarma-Sthanik Abhyang with Murchit Tila Taila and Nadi Sveda will be done on the lower abdomen, back and both the legs till samyak sved lakshnas. Pradhana Karma: Patient will be asked to lie in the left lateral position by keeping left leg straight and right leg flexed at the knee joint. Also the left hand should be kept folded behind the head, without th)
(1) Medicine Name: Yuktaratha Basti:Ingredients- Madhu– 100ml Saindhava Lavana– 10 gms Sneha Dravya – Murcchita Tila Taila 120ml Kalka Drvya – Vacha+Pippali + Madanphala 40gms Kashaya – Erandamoola 300ml Total - 570 ml , Reference: Sh.Sa.U.6/33, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 570(ml), Frequency: od, Duration: 8 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients presenting classical sign and symptomes of Gridhrasi w.s.r. to Sciatica.
Patient fit for Basti Karma.
Straight leg raising test being positive.
Age group between 20 to 70 years in both sexes.
Duration of illness upto two years.
Non-involvement of urinary bladder and rectum. 
 
ExclusionCriteria 
Details  Duration of disease more than two years.
Patient not fit for Basti.
Monoplegia,paraplegia.
Hip joint arthritis,ankylosing spondilitis,T.B. spine/hip,osteomyelitis,malignancy.
Pelvic pathology.
Traumatic lesion in lumbosacral region,lumbar surgery,fracture and severe spinal canal stenosis of spinal cord.
Patient with other severe systemic metabolic disorders like hyperthyroidism,cardiac diseases, etc.
Patient who are regular on/using NSA IDs and steroid dependent.
Degenerative disorders with marked deformity.
Pregnant women and lactating mothers.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To Asses The Efficacy of Yuktaratha Yoga Basti and Siddha Yoga Basti in Gridhrasi With Special Reference to Sciatica.  at Baseline and on 8 Days and on 16 Days

 
 
Secondary Outcome  
Outcome  TimePoints 
To Evaluate the symptomatic relief of Gridhrasi by the action Yuktaratha Yoga Basti & Siddha Yoga Basti over the course of study.
To asses & compare Laboratory investigation parameters like CBC,RBS & ESR between Yuktaratha Yoga Basti & Siddha Yoga Basti in Gridhrasi w.s.r. to Sciatica.

To study the mode of action of Yuktaratha Yoga Basti & Siddha Yoga Basti in Gridhrasi with special reference to Sciatica.
To evaluate the efficacy of drugs in view of symptoms of patient.
To evaluate the other associated benefits during the treatment period.
To study the Etiopathogenesis, Symptoms, Diagnostic tools, Prognosis & Treatment of Gridhrasi & Sciatica as per Ayurvedic & Modern texts 		 at Baseline 8 days 16 days 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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 3 
Date of First Enrollment (India)   20/11/2023 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  
The Change of life style of Human being in developing countries has created several disharmonies in his biological system. Factors like improper sitting postures in office, jerking movements in travel & sports lead to Gridhrasi w.s.r. to sciatica due to pressure on spine.
This disease is not only inflict pain, but also causes difficulty in walking. It disturbs daily routine and overall life of the patients because of continuous and stretching type of pain.
This study is Comparative Clinical Study of Yuktaratha Yoga Basti and Siddha Yoga Basti in Gridhrasi w.s.r. to sciatica.
This study includes Yuktaratha Yoga Basti as a trail group and Siddha Yoga Basti as a control group.
Study will be conducted in India. With the help of Subjective and Objective Criteria; assessment will be done. As per Data; proper Statistical test will be applied and then Observation, Result, Discussion  and lastly Conclusion will be drawn.
 
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