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CTRI Number  CTRI/2022/10/046583 [Registered on: 18/10/2022] Trial Registered Prospectively
Last Modified On: 18/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To study efficacy of 5ml castor oil with 50ml dry ginger decoction in the management of lower back pain with special reference to Chakradatta 
Scientific Title of Study   Randomised clinical trial to study efficacy of Eranda Sneha(5ml)with Shunthi Kwatha(50ml) in the management of Katishoola with special reference to Chakradatta. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Simaran Gani Mulla 
Designation  M.D. Scholar Ayurveda Samhita And Siddhant 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Pune 
Address  Department of Ayurveda Samhita and Siddhant, Sane Guruji Arogya Kendra, Malwadi road Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9021059794  
Fax    
Email  simaranm1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilesh Kulkarni 
Designation  Professor 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Pune 
Address  Department of Ayurveda Samhita and Siddhant, Sane Guruji Arogya Kendra, Malwadi road Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  8805335512  
Fax    
Email  prof.dr.nileshkulkarni@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Simaran Gani Mulla 
Designation  M.D. Scholar Ayurveda Samhita And Siddhant 
Affiliation  MAMs Sumatibhai Shah Ayurved Mahavidyalaya, Pune 
Address  Department of Ayurveda Samhita and Siddhant, Sane Guruji Arogya Kendra, Malwadi road Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9021059794  
Fax    
Email  simaranm1@gmail.com  
 
Source of Monetary or Material Support  
Department of Ayurved Samhita and Siddhanta, Sane Guruji Arogya Kendra, Malwadi Road Hadapsar Pune 
 
Primary Sponsor  
Name  Sane Guruji Arogya Kendra 
Address  Department of Ayurveda Samhita and Siddhant, Sane Guruji Arogya Kendra, Malwadi road Hadapsar Pune 
Type of Sponsor  Research institution and hospital 
 
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 Simaran Gani Mulla  Sane Guruji Arogya Kendra  Department of Ayurveda Samhita and Siddhanta ,Attacted OPD of Sane Guruji Arogya Kendra,Malwadi Road Hadapsar , pune
Pune
MAHARASHTRA 		 9021059794

simaranm1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution Ethical committee  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, (2) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATAPRAKOPAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Eranda sneha , Reference: Chakradatta , Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Shunthi kwatha ), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients having symptom of Katishool more than 7 days and less than 3 months.
2. Avarodha Janya Samprapti.
3. No specific and major pathology of degenerative changes
4. Gender - Male and Female
 
 
ExclusionCriteria 
Details  1.Taking NSAIDs
2.Patient having inborn structural deformities.
3. Diagnosed with Fracture of Lumbar Spine etc. and needs surgical intervention
4.Patients having other joint deformities or diseases which are not related to Katishoola.
5. Katishoola is associated with known case of Cardiac disease, Pulmonary TB, Pregnancy, Paralysis, Neurological disorder, HIV or any other relevant pathology.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome is assessment of Katishoola with pain scale  intervention for consecutive 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Comparative analysis of pain and functional improvement
 		 Day 1 and Day 7 2visit 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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/ Phase 3 
Date of First Enrollment (India)   31/10/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  31/10/2022 
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   Not Yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   The study will be done on the patients selected on the basis on inclusion criteria, The initial assessment will be done on 1st day. Then the treatment will be started (Erand sneha 5ml with sunthi kwatha 50ml before dinner for seven days. On 8th day follow up will be done. Result of 1st day assessment will be compared with 8th day assessment. Result will be drawn after discussion and conclusion based on statistical analysis  
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