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CTRI Number  CTRI/2023/01/048863 [Registered on: 10/01/2023] Trial Registered Prospectively
Last Modified On: 05/01/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative clinical trial to study the effect of katibasti with sahchar tail and short wave diathermy along with matrabasti with sahchar tail in the management of katigrah. 
Scientific Title of Study   A RANDOMISED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF KATIBASTI WITH SAHACHAR TAIL AND SHORT WAVE DIATHERMY ALONG WITH MATRA BASTI WITH SAHACHAR TAIL IN THE MANAGEMENT OF KATIGRAHA.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amit kumar miree 
Designation  PG Scholar 
Affiliation  Parul Ayurved Hospital 
Address  Panchkarma-OPD No 105 and IPD ,Parul Ayurved hospital,Parul University, limda,Tal.Waghodia-391760,Dist Vadodara,GUJRAT, India

Vadodara
GUJARAT
391760
India 
Phone  7999237638  
Fax  02668-260201  
Email  amitmiri1992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrNirmala Sonawane 
Designation  Associate professer 
Affiliation  Parul Ayurved Hospital 
Address  Room No 303 Department of Panchkarma ,Parul Institute of Ayurved,Parul University, limda,Tal Waghodia-391760,Dist-Vadodara,GUJRAT, India

Vadodara
GUJARAT
391760
India 
Phone  8329614671  
Fax  02668-260201  
Email  ayurved05@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrNirmala Sonawane 
Designation  Associate professer 
Affiliation  Parul Ayurved Hospital 
Address  Room No 303 Department of Panchkarma ,Parul Institute of Ayurved,Parul University, limda,Tal Waghodia-391760,Dist-Vadodara,GUJRAT, India

Vadodara
GUJARAT
391760
India 
Phone  8329614671  
Fax  02668-260201  
Email  ayurved05@gmail.com  
 
Source of Monetary or Material Support  
panchakarma - OPD no 105 and IPD -Parul Ayurveda Hospital,Parul University,Limda,Vadodara,Gujarat,Pin no-391760 
 
Primary Sponsor  
Name  Parul Ayurved Hospital 
Address  panchakarma - OPD no 105 and IPD -Parul Ayurveda Hospital,Parul University,Limda,Vadodara,Gujarat,Pin no-391760  
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 
DrAmit kumar miree  Parul Ayurved Hospital  Panchakarma-OPD no 150 and IPD, Parul University,Limda,Vadodara,Gujrat Pin no-391760, Vadodara,Gujrat
Vadodara
GUJARAT 		 7999237638
02668-260201
amitmiri1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: KATIGRAHA, ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Katibasti,matra basti, short wave diathermy (Procedure Reference: , Procedure details: SOP OF KATIBASTI WITH SAHACHARA TAILA Poorva Karma (Pre-operative procedure) • In morning time after the evacuation of natural urges, the patient will be asked to wear minimum dress and comfortably lie down in prone position with well exposed Katipradesha, over Droni. • Black gram flour (250gm), sahachar taila (500ml) , Vessel-(2), spoon-(1) Note-250ml will be used for first 3 days rest 250ml will be used for rest 4 days. • Prepared dough is fixed on the area to be treated in a cir)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients presenting with clinical sign and symptoms of katigraha .
2. Katigraha patients between the age group of 20 to 60 years.
3.Patients of either gender irrespective of caste and religion.  
 
ExclusionCriteria 
Details  1.Patients suffering from any metabolic and systemic disorders
2.Patients with history of trauma
3.Post-surgical backache
4.Pregnancy
5.Patients suffering from Spondylolisthesis, Spina bifida, Tuberculosis of Spine, Ankylosing Spondylitis, Spinal Canal Stenosis and Malignancies. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Helps in reduction of signs and symptoms of Katigraha and recurrence of the disease will be controlled.  8days of treatment
after 14 ays of treatment follow up. 
 
Secondary Outcome  
Outcome  TimePoints 
There will be increased quality of life in lowbackpain patients and complications of the diseases will be reduced.  25 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/01/2023 
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="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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [amitmiri1992@gmail.com].

  6. For how long will this data be available start date provided 25-01-2023 and end date provided 31-03-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Lower back pain is one of the common musculoskeletal diseases affecting of the world’s. In the prevalence rate of India was 9.4%. To date, no proper curative measures are found to treat lower back pain in modern science.As per Ayurveda’s unique treatment of basti karma here is an attempt to study the efficiency of katibasti with sahachar tail and short wave diathermy along with Matra basti with sahachar tail in the management of Katigraha. 

RESEARCH QUESTIONS:   
Which is the more effective therapy for the management of Katigraha- katibasti or SWD along with Matrabasti?



AIM:
To Compare the Efficacy of Katibasti with Sahachara taila and matra basti Sahachar tail and physiotherapy in the Management of Katigraha

OBJECTIVES:
1. To evaluate the efficacy of Kati basti with sahachar tail and matrabasti with Sahachar tail in the management of Katigraha.
2. To evaluate the efficacy of SWD and matra basti with sahachar tail in the management of Katigraha.
3. To compare the efficacy of Katibasti with sahachar tail and SWD along with matrabasti with Sahachar tail in the management of Katigraha.

MATERIAL AND METHODS:
Duration of study:  14 months.
Study design : Randomised comparative clinical study.
Purpose of the study will be explained and written informed consent will be taken from every patient.

SOURCE OF DATA:1. Source of data:
i. Literary source:
All the available literature regarding, katigraha, Sahachara, Katibasti Matrabasti and SWD in classical treatises and contemporary texts including journals and online sources will be reviewed and documented for the study.

ii. Pharmaceutical source:
  Medicine will be prepared in the GMP certified Teaching Pharmacy of Parul Institute of Ayurveda.



iii. Clinical source:
Patients diagnosed to be suffering with Katigraha and indicated for Swedana will be randomly selected for the study from OPD and IPD of Parul Ayurved Hospital.


TREATMENT GROUPS
Group A   :  Kati basti with sahachara tai and along with matra basti will be administered on 30 patients for 7 days.

Group B : SWD and Matra basti with sahachara tail  will be administered on 30 patients for 7 days.





SUBJECTIVE CRITERIA:

i. Pain
ii. Stiffness
iii. Restricted movements

 OBJECTIVE CRITERIA:
i. Lumbar flexion
ii. Lumbar extension
iii. Left Lateral movement
iv. Right lateral movement
v. Rotation
vi. Walking time
vii. VAS scale





INTERVENTION:


 1st day2nd day  3rd day4th day  5th day 6th day 7th day 
 Katibasti Katibasti Katibasti Katibasti Katibasti Katibasti Katibasti


 1st day2nd day 3rd day 4th day 5th day 6th day 7th day 
 Matra bastiMasti basti Matra basti Matra basti Matra basti Matra basti Matra basti 




Katibasti: 7 days
Short wave diathermy :7days
Matra basti: 7days

Quantity:
Katibasti:500ml 
Matra basti:525 ml
S.W.D. 20mint

Follow up after 7th and 14 th days of discharge.
Samyak katibasti lakshan:
i. Sheeta Uparama ( Relief of coldness)
ii. Shoola Uparama (Relief of pain)
iii. Stambha Nigraha (Relief of stiffness)
iv. Gaurava Nigraha (Relief of heaviness)
v. Mardava (Softness of the body)
vi. Sweda (Adequate sweating)
vii. Vyadhihani (Remission of disease)


Samyak basti lakshan:
i. Sapurisha Sneha pratyeti
ii. Vatanulomana
iii. Agnidipti
iv. Srusshacha vega
v. Sharir laghavata
vi. Sharir bala

Samyak lakshan of Short wave diathermy:
Relief in Pain
Relief in Stiffness
Relief Tenderness 
Relief in heaviness
Remission of disease
 
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