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CTRI Number  CTRI/2024/08/072255 [Registered on: 09/08/2024] Trial Registered Prospectively
Last Modified On: 03/08/2024
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   Effect of Yashtimadhu in Asthibhagna(Fracture) 
Scientific Title of Study   A Randomised Controlled Clinical Trial To Study The Effect Of Yashtimadhu in Asthibhagna With Special Reference To Closed Undisplaced Fracture  
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 Rahul Suresh Kokare 
Designation  PG Student 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Shalyatantra SMBT Ayurved college and Hospital Dhamangaon Nashik

Nashik
MAHARASHTRA
422403
India 
Phone  9096252158  
Fax    
Email  rahulkokare1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Datta Bhikan Kumavat 
Designation  Professor 
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Shalyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India

Nashik
MAHARASHTRA
422403
India 
Phone  9049059799  
Fax    
Email  drdkumavat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul Suresh Kokare  
Designation  Post Graduate Student  
Affiliation  SMBT Ayurved College and Hospital 
Address  Department of Shalyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India

Nashik
MAHARASHTRA
422403
India 
Phone  9096252158  
Fax    
Email  rahulkokare1997@gmail.com  
 
Source of Monetary or Material Support  
Department Of Shalyatantra SMBT Ayurved College And Hospital Dhamangaon Nashik Maharashtra 422403 INDIA 
 
Primary Sponsor  
Name  Dr Rahul Suresh Kokare 
Address  Department Of Shalyatantra SMBT Ayurved College And Hospital Dhamangaon Nashik Maharashtra 422403 INDIA 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Rahul Suresh Kokare  SMBT Ayurved College And Hospital  Department Of Shalyatantra OPD no 3 Dhamangaon Nashik
Nashik
MAHARASHTRA 
9096252158

rahulkokare1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMBT Ayurved College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M843||Stress fracture. Ayurveda Condition: BAGNAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yashtimadhu, Reference: Charak Samhita Sutra Sthana, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 25 Days, anupAna/sahapAna: Yes(details: -Cow Milk), Additional Information: -
2Comparator Arm (Non Ayurveda)-Tablet Calcium carbonate Dose 500mg Frequency twice a day with water Duration 25 days Route oral
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details 
1) Patients will be selected Irrespective of caste, religion, gender and socio-economic status.
2) Patients with closed un-displaced (long bone) fractures will be Included.
 
 
ExclusionCriteria 
Details  1) Patients other than closed un-dispaced fractures are excluded.
2) Patients with known case of Diabetes Mellitus, Hypertension will be excluded.
3) Patients with pathologiacal fracture like osteoporosis will excluded.
4) Fractures requiring open reduction and internal fixation.
5) Patients with previous non-union, metastatic tumor will be excluded.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in sign and symptoms of asthibhagna after ingestion of Yashtimadhu   For 25 days 
 
Secondary Outcome  
Outcome  TimePoints 
Where The Trial Group Stands In Comparison With Control Group  18 Months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   15/08/2024 
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 Yet Recruiting 
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  

  An evolution of human life began thousands of decades ago. As humans got evolved they dealed with health issues and to overcome this Ayurveda too took birth with humans. Ayurveda has maintained its herbal, panchabhautika therapies from that era till today. A frame work of body is formed by Asthi dhatu and due to trauma asthi dhatu gains discontinuation which is well stated in its nirukti .

अस्थिविश्लेषोऽत्र भङ्गेऽभिप्रेतः।

                       à¤®à¤¾. नि. मधुकोष टीका (४४/१)

          There are main two types of bhagna namely sandhimukta and kandbhagna which are further classified into 6 and 12 types respectively . Fracture not only restricts the physical movements but also cuts the social, economical, psychological movements of the patient. If proper management of Asthibhagna in suitable period is not done then it may leads to the permanent disability. Similarly, minimise the immobilisation period and early recovery with proper healing is the aim of fracture management. The principal of management of fracture includes pain management, reduction, immobilization and rehabilitation. Sushruta has been described the same principle like Anchhana (Traction), Peedana (Counter traction), Sankshepana (Correction of deformity) and Bandhana (Immobilisation) for Bhagna. A fracture is a break in the continuity of a bone. Fractures come under orthopedics branch which deals with the deformities, discontinuation related to bone. Open reduction and internal fixation are the procedures which are carried out when fractures are open but even some close fractures to need internal fixation. In this study, closed un-displaced fractures are going to be considered with POP slab.In Ayurveda management of fracture is done with immobilizing fracture with kusha (splint) which was prepared with application of lepa of wound-healing medicines with internal medication prepared from medicines having sandhaneeya effect. Apart from this many herbo-organic drugs are prescribed for early healing of fracture. Yashtimadhu is simple, easily available, cost effective and potent. The scientific evaluation of such drugs along with their fundamental principles is essential for their universal acceptance.  Yashtimadhu  being described by CHARAK SAMHITA as a medication which is given internally to the patients having fractures. Rasa, guna, virya, vipak of Yashtimadhu acts on dosha dhatu so that it can help in healing of bone. Yashtimadhu being a drug which even has its Sandhaneey and anti-inflammatory properties.

 
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