| CTRI Number |
CTRI/2024/10/075267 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
04/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomised controlled clinical compare the efficacy of arjunadiyog and calcium tablet in fracture. |
|
Scientific Title of Study
|
Randomised controlled clinical trail to compare the efficacy of arjunadiyog and calcium tablet in kanda bhagna |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaibhav Vijay Khondil |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9325323457 |
| Fax |
|
| Email |
vkhondil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin D Nalawade |
| Designation |
Associate Professor Shalyatantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9822522905 |
| Fax |
|
| Email |
nalawadenitin54@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaibhav Vijay Khondil |
| Designation |
MS Scholar Shalyatantra |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune.
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA
411011
India |
| Phone |
9325323457 |
| Fax |
|
| Email |
vkhondil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011,
Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurveda Mahavidyalaya |
| Address |
Tilak Ayurveda Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune 411011 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vaibhav Vijay Khondil |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Ayurved Mahavidyalaya Department of Shalyatantra 2nd
floor 583/2 Rasta Peth Pune.
Pune
MAHARASHTRA |
09325323457
vkhondil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: BAGNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Arjunadi Yog, Reference: Bhavprakash Bhagna Adhikar 48/29, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Lukewarm Water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Calcium tablet | Calcium supplements are salts of calcium used in a number of conditions.Supplementation is generally only required when there is not enough calcium in the diet.By mouth they are used to treat and prevent low blood calcium, osteoporosis, and rickets. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients of long bone Fracture of upper and lower limb will be selected
Patients of either sex will be selected
Patients of age group of 18 onwards will be selected |
|
| ExclusionCriteria |
| Details |
Patients with a history of Pathological Fracture, Nonunion will be excluded.
Patients with the localized defects like, Solitary bone cyst, Metastatic tumour will be
excluded.
Patients with acquired anomalies like Osteomyelitis, RA. will be excluded.
Compound fracturesin which complicationslike injury to the blood vessels or nerves are excluded
All fractures, except upper and lower limb will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in Shool, Shotha and normal range of serum alkaline phosphate |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in Shool, Shotha and normal range of serum alkaline phosphate |
45 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)
|
23/10/2024 |
| 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
|
The study will be intervened by the treatment of Arjunadiyog and calcium tablet to group A and group B respectively. The efficacy of the therapy will be assessed on the
basis of subjective criteria for statistical analysis. Scoring will be designed according to the severity
of symptoms. The subjective gradation of symptoms will be done as follows and the intensity of
each symptom will be calculated before treatment, after treatment and after follow up. The effect of
treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading
and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring
method. |