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CTRI Number  CTRI/2022/01/039142 [Registered on: 04/01/2022] Trial Registered Prospectively
Last Modified On: 04/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda
Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparison between Marma therapy and Kati basti in low back pain treatment 
Scientific Title of Study   An Anatomical study on Katikataruna Marma and its clinical application in comparison to Kati Basti on Katisula (Low back pain) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anurag Tiwari 
Designation  MD Scholar 
Affiliation  Faculty of Ayurved , IMS-BHU 
Address  Department Of Rachana Sharir Faculty of Ayurveda IMS-BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  8874388783  
Fax    
Email  anurag7236@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Vijay Laxmi Gautam 
Designation  Professor 
Affiliation  Faculty of Ayurved , IMS-BHU 
Address  Dept. of Rachana Sharir Faculty of ayurveda Ims,Bhu

Varanasi
UTTAR PRADESH
221005
India 
Phone    
Fax    
Email  vlaxmi40@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anurag Tiwari 
Designation  MD Scholar 
Affiliation  Faculty of Ayurved , IMS-BHU 
Address  Department of Rachana Sharir Faculty of Ayurveda IMS-BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone    
Fax    
Email  anurag7236@gmail.com  
 
Source of Monetary or Material Support  
Department of Rachana sharir IMS, BHU 
 
Primary Sponsor  
Name  Anurag Tiwari 
Address  Dept. of Rachana Sharir , Faculty of ayurveda , IMS , BHU, Varanasi 
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 
Anurag Tiwari  Sir Sundarlal Hospital , IMS BHU  Sir Sundarlal Hospital Opd 16 C Ayurveda Wing , institute of medical sciences, BHU , varanasi, up
Varanasi
UTTAR PRADESH 
8874388783

anurag7236@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M519||Unspecified thoracic, thoracolumbar and lumbosacral intervertebral disc disorder. Ayurveda Condition: KATISHULA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-marmacikitsA, मर्मचिकित्सा (Procedure Reference: Sushruta sharir sthan chapter 6, Procedure details: katikataruna marma chikita 16-18 times per minute for 5 minute twice daily)
(1) Medicine Name: Tryodasang gugglu with dasmool kwath, Reference: Bhaisjyaratnawali, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Duration: 2 Months
2Intervention ArmProcedure-kaTibastiH, कटिबस्तिः (Procedure Reference: Panchkarma, Procedure details: Kati Basti with Mahanarayan taila (one time per day continuous for seven days for each month) .)
(1) Medicine Name: Tryodasang guggulu with dasmool kwath, Reference: Bhaisjyaratnawali, Route: Oral, Dosage Form: Guggulu, Dose: 1(g), Frequency: bd, Duration: 2 Months
3Comparator ArmDrugClassical(1) Medicine Name: Tryodasang Guggulu, Reference: Bhaisjyaratnawali, Route: Oral, Dosage Form: Guggulu , Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Dasmool kwath), Additional Information:
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Clinical symptoms of low back pain with or without radiological changes. 
 
ExclusionCriteria 
Details  1. Patients below 20 years and above 60 years of age will be excluded.
2. Patient suffering from paralysis.
3. Uncontrolled diabetes mellitus, cardiovascular disease, neoplastic disorders.
4. Pregnancy
• Severely malnourished, debilitated
• Myelopathy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Pain in low back is studied  At duration of 30 days, 60 days. 
 
Secondary Outcome  
Outcome  TimePoints 
Stiffness in low back , numbness and weakness of lower limb are studied.  At duration of 30 days , 60 days. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   05/01/2022 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Comparative study between ayurvedic medicine treatment , marma therapy treatment and kati basti treatment of Katishula is done 
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