This study is open label clinical study to evaluate the effect of Musta Aargavadhadi kasaya on sthaulya.
Routine blood investigation will be performed to rule out other
systematic pathology.
Special scoring scale has been prepared based on information in
Ayurvedic classical texts which will be utilized for assessment and evaluation
PLAN OF STUDY:
Materials & Methods: Clinical
material would be the patients, drug and research plan. Clinical study will be
started only after getting clearance from institutional ethics committee.
SELECTION OF THE PATIENTS:
Inclusion Criteria:
- Patients between the age group of 20 years to 50 years and
having classical signs and symptoms of Sthaulya i.e. Chala Sphik
Udara Stana, Angagandha, Swedadhikya, Kshudhadhikya, Pipasadhikya ,
Kshudra Shwasa , Nidradhikya will be selected, irrespective of sex,
religion etc. from the O.P.D. and I.P.D. of I.P.G.T and R.A. Hospital,
G.A.U. Jamnagar.
- Detailed clinical history will be taken on specially prepared
research proforma and filled in the record of B.T. and A.T. data for the
statistical study.
- B.M.I. - 25 Kg/m2
to 35 Kg/m2
Exclusion Criteria:
1. Age
of patient less than 20 years and more than 50 years.
2.
Patients having major illness
like cardiac diseases, diabetes mellitus etc & also the involvement of
other systemic disorders.
3.
Patients having Sthaulya due to
genetics, pregnancy, drug induced, cushing’s syndrome, hypothyroidism, other
hormonal disorder and related to any disease
Investigations:
Investigations will
be done before treatment to rule out any other associated pathology. Only
important investigations related to the study will be repeated after treatment
if needed.
- Blood: Complete blood count and Heamogram
- Biochemical
examination: FBS, Sr. Cholesterol, Sr. Triglyceroides, HDL, LDL,
VLDL.
- Thyroid function test: T3, T4, TSH- When and where required.
Objective Criteria:
It will be mainly assessed on the basis of Body weight , BMI and body fat
percentage before starting the treatment and after completion of the treatment
in terms of percentage relief and statistical evaluations.
For the present study the girth measurements
of certain regions using measuring tape before and after the treatment will
also be carried out. The girth measurement of following areas where will be
taken into consideration.
1. Neck -
At the level of Thyroid
cartilage.
2. Chest - In normal expansion at the level of
nipple.
3. Abdomen - At the level of umbilicus.
4. Hip - At the level of highest point of
distention of buttock
5. Mid arm - Mid of the arm between shoulder
joint and elbow joint.
6. Mid thigh
- Mid of the thigh between
pelvic and elbow joint.
In case of girth measurements, the mean
values of both sides will be taken before and after treatment.
The effectiveness of therapy on body fat will
be assessed by measuring the skin fold thickness by Vernier calipers before and
after the treatment in some particular areas like,
1. Skin fold thickness of the middle portion
of the Biceps muscle.
2. Skin fold thickness of the middle portion
of the Triceps muscle.
3. Skin fold thickness of the inferior
portion of the scapula.
4. Skin fold thickness of the abdomen.
The skin fold measurement will be carried out
bilaterally after exposing the skin properly in the above mentioned region. The
superficial skin along with subcutaneous fat but except muscles a clinch will
be made and the proportionate, which is stretched as skin fold will be measured
by placing it between two points of Vernier Calipers. For all the regions, the
mean values of both sides of the body before and after the treatment will be
recorded.
Grouping:
Patients
will be randomly divided into below mentioned 2 groups:
Group A:
Musta Aragvadhadi Kashaya (Ca. Su. 23/12)
Group B: Placebo Capsule.
Patients of both the groups will be
suggested similar type of Vyayama and Pathyapathya
Dose & Posology :Group A
Matra (dose) : 2 pala-100ml
Kala : Nirann pratah evum sayam Kale
Anupana : Sukhosna jal (Luke
warm water)
Duration: 60 days
Preparation
of kwath :
Kwath of above mentioned drugs will
be prepared by classical Ayurvedic method. Mixed rough powder of Kwathdravya
will be boiled with quality sufficient water up to the evaporation of ¾ parts.
Remaining part (1/4 ) with filtered and will be used as medicine.
Group B: Placebo
Cap.(Rosted sauji) :
Dose
–2 Capsules of 500 mg.
Kala
- Before meals two times.
Anupana- Sukhosna jal( Luke warm water )
Criteria for assessment:
1. A
special scoring pattern will be developed for assessing improvement in signs
and symptoms before and after treatment.
2.
Laboratory investigations
conducted before and after treatment will also be considered as assessment
criteria.
3.
Assessment of BMI, body fat
percentage, reduction in weight and girth measurements.
The
obtained data will be analyzed statistically and presented along with
explanatory notes, discussion and conclusion.
|