A Randomised controlled clinical trial to study the effect of Asthisandhankar vati in Asthibhagn w.s.r.t closed undisplaced fracture.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 74
- Locations
- 1
- Primary Endpoint
- To observe the effect of Asthisandhankar Vati as Bone healing
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient’s age group 18 to 50 will be selected.
- •Patients with closed un-displaced (long bone) fractures will be Included.
- •Hairline fracture.
Exclusion Criteria
- •Patients other than closed un-dispaced fractures are excluded.
- •Patients with known case of Diabetes Mellitus, Hypertension will be excluded.
- •Patients with pathologiacal fracture like osteoporosis will excluded.
- •Fractures requiring open reduction and internal fixation.
- •Patients with previous non-union, metastatic tumor will be excluded.
Outcomes
Primary Outcomes
To observe the effect of Asthisandhankar Vati as Bone healing
Time Frame: 25 days
Secondary Outcomes
- To study the callus formation using X-ray.(To study the pain relief using the vas scale.)
Investigators
Dr Mayur Ganesh Ingole
ASS Ayurved Mahavidyalaya Nashik