| CTRI Number |
CTRI/2025/05/086694 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect Of Jambu Beej Churna in Asthibhagna (fractures) |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To study The Effect Of Jambu Beej
Churna In The Management of Asthibhagna With Special Reference To Closed
Un-displaced Fractures |
| 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 Ashwini Kiran Walinjkar |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
Department of Shalyatantra SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9545710866 |
| Fax |
|
| Email |
ashwiniwalinjkar99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Datta Kumavat |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
Department of ShalyatantraSMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9049059799 |
| Fax |
|
| Email |
drdkumavat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Kiran Walinjkar |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved college and Hospital |
| Address |
Department of Shalyatantra SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA
422403
India |
| Phone |
9545710866 |
| Fax |
|
| Email |
ashwiniwalinjkar99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra,India |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini Kiran Walinjkar |
| Address |
SMBT Ayurved College and Hospital Nandi hills Dhamangaon
Igatpuri Nashik 422403 Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Ashwini Kiran Walinjkar |
SMBT Ayurved college and Hospital |
OPD NO 4 Department of Shalyatantra SMBT Ayurved college and Hospital Nandi hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA |
9545710866
ashwiniwalinjkar99@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M843||Stress fracture. Ayurveda Condition: BAGNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jambu Beej Churna , Reference: Sushruta Samhita by Dr.Kaviraj Ambikaduttashastri sutrasthan Chapter 38 shloka 48 49 page no187, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 25 Days, anupAna/sahapAna: Yes(details: -Jal), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Calcium Carbonate and Vitamin D3 | Route Oral
Dosage Form Tablet
Dose 500 mg
Frequency OD
Bhaishajya Kal After Meals
Duration 25 Days
Anupana Warm Water
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients between 18 to 50 years old will be selected.
2) Patients will be selected Irrespective of caste, religion, gender and socioeconomic status.
3) Patients with closed undisplaced fractures will be Included. |
|
| ExclusionCriteria |
| Details |
1) Patients other than closed un-displaced fractures are excluded.
2) Patients with known case of Diabetes Mellitus, Hypertension will be excluded.
3) Patients with pathological fracture like osteoporosis will excluded.
4) Fractures that require open reduction and internal fixation.
5) Patients with a history of previous nonunion, metastatic tumour will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Asthibhagna after ingestion of Jambu beej churna |
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 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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
|
In Ayurveda, the body is made up of different dosh, dhatu, mala including bones (Asthi dhatu), which provide the framework for our body. But when we get hurt or injured, our bones can get damaged or broken, leading to health problems, Asthi dhatu can become disrupted or discontinuous. A fracture is a break in the continuity of a bone . he prevalence rate of closed Un-displaced fracture is 15% . jambu beej churna has been selected which acts as Kashaya rasa have sandhaneeya effect and its madur rasa it is vatashamak and due to its sheet virya it is saptadhatuvardhak, sthirikaran, prinan .The beej of the plant with chemical constituents such as Carbohydrates, calcium, magnesium, phosphorus,tannin, oxyalic acid, jamboline. Patient’s between 18 to 50 years old will be selected. Patients will be selected Irrespective of caste, religion, gender and socio-economic status.Patients with closed un-displaced fractures will be Included. Written consent from patient will be taken prior to study . Computerised generated sampling technique will be used .total 70 number of patients will be selected and divided into two groups ,name as Group A (trial group ) Group B ( control group) . Jambu beej churna group A (trial group ) with dose 3gm od and Anupan jal and tab calcium group B (control group ) with dose 500 mg od and anupan jal will be given to patients . Both drugs will administered orally for 25 days .observation will be done on day 1 ,day 8 , day 16, day 25, day 33 .Result of study will be drawn on the basis of criteria of assessment and statistical analysis . Discussion will be done on the basis of observations and result obtained during the treatment. Summary will be drawn and whole thesis work will be summarised . Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased. |