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CTRI Number  CTRI/2024/02/062760 [Registered on: 16/02/2024] Trial Registered Prospectively
Last Modified On: 15/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Assessment of the role of Rasnaerandadi Kashayam, Kati Basti, and Shamapakadi Aasthapana Basti in the treatment of Katigraha (Lumber disc bulging).  
Scientific Title of Study   Evaluation of the effect of Shampakadi Asthapana Vasti,Kati vasti,Rasna Erandadi Kashayam in the management of Kati Graha W.S.R. to LUMBER Disc Bulge.  
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 Sonali Dungarwal 
Designation  P G Scholar 
Affiliation  Pandit Khushilal Sharma Government Ayurveda college and Institute Bhopal 
Address  PG Department of Panchakarma, Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Nehru Nagar Kolar bypass Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  6260046384  
Fax    
Email  Sonalidungarwal123@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Babita Dash 
Designation  Lecturer 
Affiliation  Pandit Khushilal Sharma Government Ayurveda college and Institute Bhopal 
Address  PG Department of Panchakarma, Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Nehru Nagar Kolar bypass Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  8109591573  
Fax    
Email  drmissdash@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sonali Dungarwal 
Designation  PG Scholar 
Affiliation  Pandit Khushilal Sharma Government Ayurveda college and Institute Bhopal 
Address  PG Department of Panchakarma, Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute Science Hills Nehru Nagar Kolar bypass Bhopal

Bhopal
MADHYA PRADESH
462003
India 
Phone  6260046384  
Fax    
Email  Sonalidungarwal123@gmail.com  
 
Source of Monetary or Material Support  
PG Department of Panchakrma, Pt Khushilal Sharma Govt. Ayurveda College and Institute Bhopal 
 
Primary Sponsor  
Name  Pt Khushilal Sharma Govt (Autonomous) Ayurveda College and Institute Bhopal (MP) 
Address  Pt.Khushilal Sharma Government Autonomous College and Institute Science Hills Neharu Nagar Bhopal  
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 Sonali Dungarwal  Pt Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal (MP)  PG Department of Panchakarma, Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Neharu Nagar Bhopal
Bhopal
MADHYA PRADESH 		 6260046384

Sonalidungarwal123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Pt Khushilal Sharma Govt Autonomous Ayurveda College and Institute Bhopal (MP)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M518||Other thoracic, thoracolumbar andlumbosacral intervertebral disc disorders. Ayurveda Condition: PRUSHTHA-GRAHAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Physiotherapy --Short Wave Daithermy Short wave daithermy for 21 days for 20-25 minutes .
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: SU.CHI 38/43,44,45, Procedure details: KAAL BASTI KRAM AASTHAPAN BASTI WITH SHAMPAKADI KWATH AND ANUVASAN WITH TILA TAIL ,KATI BASTI WITH TILA TAIL )
(1) Medicine Name: RASNA ERANDADI KASHAYAM , Reference: SHASHTRA YOG 1/448 , Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 20(ml), Frequency: bd, Duration: 21 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients fulfilling the diagnostic criteria.
Patients willing to sign the written consent for participation in the study.
Patients fit for Basti Karma
 
 
ExclusionCriteria 
Details  Age below 21 year or above 55 years.
Patients contraindicated for Basti Karma.
Patients having Spinal tumour, Tuberculosis, Malignant disease of the pelvis, fracture of
spine, Congenital or Acquired skeletal deformity.
Any traumatic condition of spine leading to paralysis.
Recent lumbar surgery or implanted instrumentation or prosthesis.
Pregnant and lactating women.
Having Chronic pathologies eg. Ankylosing spondylosis, Rheumatoid arthritis,Psoriatic
arthritis,gouty arthritis or any other systemic illness. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is expected that at the end of the study we would be able to demonstrate the effect of Kati Basti, Shampakadi Aasthapan Basti and Rasna Erandadi Kashayam in the management of Katigraha. It is further expected that
this study would be able to provide comparative efficacy between the Ayurvedic treatment
regimen and acclaimed physiotherapy in the management of Katigraha (lumbar disc bulge). Assessment is done by symptomic relief after basti.
 		 The duration of Kati Basti and Kaal Basti is 16 days along with Rasna Erandadi Kashaya for 21 days as oral decoction. Physiotherapy in 2nd group will be done for 21 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Physiotherapy as 2nd Group is more effective than Shampakadi Niruha Basti, Kati Basti & Rasna Erandadi Kashaya in Katigraha.Symptomatic assessment is done after 21 days.Changes & grading will be assessed before & after   duration of the study is 21 days in which Kaal Basti & Kati Basti will be given for 16 days only. 
 
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 
Date of First Enrollment (India)   01/03/2024 
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="1"
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   It is expected that at the end of the study we would be able to demonstrate the effect of kati Basti ,Shampakadi Aasthapan Basti in the management of Katigrah.. It is further expected that this study would be able to provide comparative efficacy between the ayurvedic treatment regimen and acclaimed physiotherapy in the management of Katigrah (lumbar disc bulge)  
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