HYPOTHESIS:
Null
Hypotheses [H0]–
More than one -
up to three consecutive Niruha Basti
on the same day until appearance of Samyaka
Niruha Lakshan is equally effective as one Niruha Basti in a day during Kala
Basti course in the management of Gridhrasi
w.s.r. to sciatica.
Alternative
Hypothesis:
1
More than one - up to three consecutive Niruha
Basti on the same day until appearance of Samyaka Niruha Lakshan is more effective than one Niruha Basti in a day during Kala Basti course in the management of Gridhrasi w.s.r. to sciatica.
2
One Niruha Basti in a day is more
effective than More than one - up to three consecutive Niruha Basti on the same day until appearance of Samyaka Niruha Lakshan during Kala Basti course in the management of Gridhrasi w.s.r. to sciatica.
AIM
OF STUDY:
To
evaluate and to compare two different methods of Kala Basti courses in the Management of Gridhrasi w.s.r. to sciatica.
OBJECTIVES:
1.
To study the etiopathology, symptomatology and progress of Gridhrasi.
2. To observe and to analyse the Samyaka Yoga, Ayoga and Ati Yoga
Symptoms of Basti in two different
methods of Kala Basti course in the
Management of Gridhrasi.
PLAN OF STUDY: Plan of study will be carried out in following stages;
1.
Review of literature
2.
Experimental study
3.
Clinical Study
4.
Discussion and Conclusion
CRITERIA
FOR THE SELECTION OF PATIENT: For this purpose, the patients having signs and
symptoms of Gridhrasi and fulfilling
the criteria of diagnosis will be selected irrespective of their sex, caste,
religion from the O.P.D & I.P.D of Govt. Akhandanand Ayurvedic
Hospital/College, Ahmedabad & from Govt. Maniben Ayurved Hospital,
Ahmedabad.
DIAGNOSTIC CRITERIA:
SUBJECTIVE
CRITERIA: Patients with classical Sign and Symptoms of Gridhrasi, having the Lakshanas
like,
• Ruka
(~pain)
• Toda
(~pricking sensation)
• Stambha
(~stiffness)
• Muhuspandana
(~twitching)
in the Sphika (~Gluteal Region), Kati (~Waist), Prishtha,
Uru (Thigh), Janu (Knee), Jangha (Calf) and Pada
(Foot) respectively.
•
Arochaka (~Anorexia)
•
Tandra (~Drowsiness)
• Gaurava
(~Heaviness)
OBJECTIVE
CRITERIA:
• Straight Leg Raising Test
•
Lasegue’s Sign
If
one with or without other symptom fulfilling the diagnostic criteria, then the
patient will be selected for the study.
Inclusion criteria–
Patients
of either sex with age ≥ 18 years and ≤ 60 years.
Willing and able to participate in the study.
Patient having signs and symptoms of Gridhrasi fulfilling diagnostic criteria.
Patients
who are Yogya for Basti Karma.
Exclusion
criteria -
Patient having age less than 18 years
and more than 60 years.
Patients
who are Ayogya for Basti Karma.
Patients
with other uncontrolled disease conditions i.e. hypertension, diabetes
Patients
with heart disease, thyroid dysfunctions, kidney diseases, asthma etc.
Any
other morbid conditions of the spine i.e. tumors, Abscess, hematoma, etc.
STUDYDESIGN:
Study type : Interventional
Purpose : Treatment
Masking : Open label
Timing : Prospective
End point : Efficacy and Safety
No. of Group : 2 Groups
Sample size : Minimum 15 patients in each group
Sample size
justification: This study requires time & proper observation. Due to long
duration of treatment and follow up, there may be chances of withdrawal. So,
sample size has been kept 15 patients in each group.
CONSENT PROCEDURE: Written informed
consent from the patients will be taken prior to initiate the clinical
study in recruited patient.
METHOD
OF RANDOMIZATION: Diagnosed cases of Gridhrasi
where in, patients of either sex will be selected through Computer Generated
Randomization.
INVESTIGATIONS:
Following laboratory investigations were carried out before treatment to
exclude other Pathology;
• CBC (before & after treatment)
• Urine – Routine & microscopic (before &
after treatment)
• X-ray of lumbar-sacral spine- AP & Lateral
view (if necessary)
CRITERIA
FOR WITHDRAWAL:
· In
case of any complication occurs during treatment.
· Personal
reasons of the patient.
FOLLOW
UP: Follow up study will be done for the period of 2 weeks after completion of
treatment. Total duration of study: 1 month
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