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CTRI Number  CTRI/2024/11/076522 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 31/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Study To Evaluate The Efficacy of Ayurvedic Drug In Treatment of Colles Fracture. 
Scientific Title of Study   A Randomized Controlled Clinical Trial To Evaluate Sandhaneeya Effect of Rasonadiyoga In The Management Of Bahirprakoshtasthi Bhagna w.s.r To Colles 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 Mayuri Vijay Unde 
Designation  PG Scholar MS Shalyatantra 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra 415722 India.

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9820855585  
Fax    
Email  mayuriunde21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Shankarrao Borase 
Designation  HOD & Professor MS Shalyatantra 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra 415722 India.

Ratnagiri
MAHARASHTRA
415722
India 
Phone  8329008455  
Fax    
Email  dryogeshborase@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mayuri Vijay Unde 
Designation  PG Scholar MS Shalyatantra 
Affiliation  MES Ayurved Mahavidyalaya 
Address  Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri Maharashtra 415722 India

Ratnagiri
MAHARASHTRA
415722
India 
Phone  9820855585  
Fax    
Email  mayuriunde21@gmail.com  
 
Source of Monetary or Material Support  
MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722. 
 
Primary Sponsor  
Name  Dr Mayuri Vijay Unde 
Address  MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India-415722. 
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 
Dr Mayuri Vijay Unde  MESAM Parashuram Hospital  Shalyatantra OPD no-1 Ghanekhunt-Lote PIN- 415722 Tal-Khed Dist-Ratnagiri State- Maharashtra Country- India
Ratnagiri
MAHARASHTRA 		 9820855585

mayuriunde21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MES Ayurved mahavidyalaya ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:S525||Fracture of lower end of radius. Ayurveda Condition: BAGNA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Rasonadiyoga, Reference: Bhaishajyaratnavali, Route: Oral, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: antibiotic and anti inflammatory drug will be given if required.
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients in the age group 18-60 years.
2. Patients of either sex.
3. Patient who are willing for trial and ready to give informed
consent.
4.Patients having Colle’s fracture type 1 (Transverse fracture of
distal radial metaphysis) and type 2 (type 1 + ulnar styloid
fracture) [FRYKMAN CLASSIFICATION] which can be reduced by
closed reduction method with or without general anaesthesia.
5. Fractures of styloid process of ulna.
6. Cracked, broken and displaced colle’s fracture.
7. Patients requiring external fixation and k- wiring.
 
 
ExclusionCriteria 
Details  1.Patients above the age of 60 years and below the age of 18
years.
2. Patients having uncontrolled diabetes and hypertension, SERO
positive, tuberculosis, Cardiac or systemic disorders.
3. Patients with history of ischemic heart disease, metastatic
tumour, injury to the blood vessels and nerves.
4. Patient is not willing to undergo trials or refused to give
informed consent.
5. Fractures other than colle’s fracture.
6. Open or compound fractures.
7. Colle’s fracture having significant angulation and deformity.
8. Patients suggestive of Osteomyelitis and other bone diseases
9. Radio-ulnar Subluxation.
10. Fractures requiring open reduction and internal fixation. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the sandhaneeya effect of Rasonadiyoga in the
management of Bahirprakoshtasthi bhagna w.s.r to Colle’s 
fracture. 		 6 weeks study with follow up on 14th,28th, 42nd day 
 
Secondary Outcome  
Outcome  TimePoints 
1. To provide cheap, economic and side effect free drug for the
promotion of bone healing.
2. Literature study of the bhagna and bhagna chikitsa from
ayurvedic text.
3. Literature study of the fracture and fracture healing from 
modern text. 		 6 weeks study with follow up on 14th,28th, 42nd day 
 
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)   15/11/2024 
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   Title-RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE SANDHANEEYA EFFECT OF RASONADIYOGA IN THE MANAGEMENT OF BAHIRPRAKOSHTASTHI BHAGNA W.S.R TO COLLE’S FRACTURE.


Null Hypothesis (H0) :  Rasonadiyoga is not effective in the management of Bahirprakoshasthi  bhagna w.s.r. Colle’s fracture.


Alternative Hypothesis (H1) : Rasonadiyoga is effective in the management of Bahirprakoshasthi  bhagna w.s.r to Colle’s fracture.


Study design– Randomized Controlled Clinical Trial


(1)Inclusion criteria-
1. Patients in the age group 18-60 years.
2. Patients of either sex.
3. Patient who are willing for trial and ready to give informedconsent.
4.Patients having Colle’s fracture type 1 (Transverse fracture of distal radial metaphysis) and type 2 (type 1 + ulnar styloid fracture) [FRYKMAN CLASSIFICATION] which can be reduced by closed reduction method with or without general anaesthesia.
5. Fractures of styloid process of ulna.
6. Cracked, broken and displaced colle’s fracture.
7. Patients requiring external fixation and k- wiring.


(2) Exclusion criteria-
1. Patients above the age of 60 years and below the age of 18 years.
2. Patients having uncontrolled diabetes and hypertension, SERO positive, tuberculosis, Cardiac or systemic disorders.
3. Patients with history of ischemic heart disease, metastatic tumour, injury to the blood vessels and nerves.
4. Patient is not willing to undergo trials or refused to give informed consent.
5. Fractures other than colle’s fracture.
6. Open or compound fractures.
7. Colle’s fracture having significant angulation and deformity.
8. Patients suggestive of Osteomyelitis and other bone diseases
9. Radio-ulnar Subluxation.
10. Fractures requiring open reduction and internal fixation.

Sample size- total 60 (30 for each group)

Patients coming to OPD, IPD and patients of Orthopaedician attach to our hospital with Bahirprakoshasthi  bhagna ( Colle’s fracture ).
Simple randomized sampling (Lottery method)

Group A - Rasonadiyoga

Group B - Syrup Calcium + vitamin D3

Total duration of drug administration is 6 weeks. The mode of drug administration will be by oral route.

Follow up- Follow up will be on 14th, 28th, 42nd day.

Result- Result will be drawn as per assessment criteria and statistical analysis.
 
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