| 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
|
|
|
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
|
|
|
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: 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: - | | 2 | Comparator 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 . असà¥à¤¥à¤¿à¤µà¤¿à¤¶à¥à¤²à¥‡à¤·à¥‹à¤½à¤¤à¥à¤° à¤à¤™à¥à¤—ेऽà¤à¤¿à¤ªà¥à¤°à¥‡à¤¤à¤ƒà¥¤ मा. नि. मधà¥à¤•ोष 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. |