FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/089921 [Registered on: 01/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
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   Ayurvedic management in fracture. 
Scientific Title of Study   A Randomised controlled clinical trial to study the effect of Asthisandhankar vati in Asthibhagn w.s.r.t 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 Mayur Ganesh Ingole  
Designation  PG Scholar Shalyatantra Dept. 
Affiliation  ASS Ayurved Mahavidyalaya Nashik 
Address  OPD no 6 Arogyashala Rugnalaya Ganeshwadi Nashik 422003
OPD no 6 Arogyashala Rugnalaya Ganeshwadi Nashik 422003
Nashik
MAHARASHTRA
422003
India 
Phone  8788054482  
Fax    
Email  mayuringole130797@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pankaj Dixit 
Designation  MS Shalyatantra  
Affiliation  ASS Ayurved Mahavidyalaya Nashik 
Address  Arogyashala Rugnalaya Ganeshwadi, Panchavati Nashik 422003
Arogyashala Rugnalaya Ganeshwadi,Panchavti Nashik 422003
Nashik
MAHARASHTRA
422003
India 
Phone  9011045371  
Fax    
Email  drpankajpdixit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mayur Ganesh Ingole  
Designation  PG Scholar Shalyatantra Dept. 
Affiliation  ASS Ayurved Mahavidyalaya Nashik 
Address  Arogyashala Rugnalaya Ganeshwadi Nashik 422003
Arogyashala Rugnalaya Ganeshwadi Nashik 422003
Nashik
MAHARASHTRA
422003
India 
Phone  8788054482  
Fax    
Email  mayuringole130797@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Mayur Ganesh Ingole  
Address  Ayurved Mahavidyalaya Panchvati Ganeshwadi Nashik 422003 
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 
Mayur Ganesh Ingole   Arogyashala Rugnalaya Ganeshwadi Nashik   OPD NO 6 Shalyatantra department Panchavati Nashik
Nashik
MAHARASHTRA 
8788054482

mayuringole130797@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: ASTHICILLITAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Asthisandhankar Vati, Reference: -, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Calcium carbonate , Reference: KD Tripathi , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: - Jal), Additional Information: -
3Intervention ArmDrugClassical
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1) Patient’s age group 18 to 50 will be selected.
2) Patients with closed un-displaced (long bone) fractures will be
Included.
3) Hairline fracture 
 
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   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To observe the effect of Asthisandhankar Vati as Bone healing  25 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study the callus formation using X-ray.
To study the pain relief using the vas scale. 
3 weeks 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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 
Date of First Enrollment (India)   15/07/2025 
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   The Ayurvedic philosophy is specific pertaining to the body constitution.
The Human body (Sharira) is described as a Combination of external
factors the Atma (soul), Manas (mind) and Pancha Maha Bhoota (five
mega elements). In all the living beings the matter and energy is existing
In the form of Dosha Dhatu & Mala. The Most important supportive
framework of the Body among these is Asthi (Bone tissue). The branch of
surgery that deals with deformities of the bones is known as Ortho-
Pedics.
Modern surgery has its aim as “maintenance of normal mechanical
function of the deformed bones’’. Trauma management has been in
practice since Vedic Periods. Ashwini Kumaras used to perform Surgeries
like limb replacement, fixation of Severed head etc. The same science was
developed, practiced, and well documented by ‘Famous Indian sage
Acharya Sushruta’.
This part of the treatment in Ayurveda is Called Bhagna Chikitsa.
There are main two types of bhagna namely sandhimukta and 
kandbhagna which are further classified into 6 and 12 types respectively 
(2). 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 (3).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 (6). Apart from this many herbo-organic drugs
are prescribed for early healing of fracture. Yashtimadhu is simple, easily
available, cost effective and potent.
 
Close