A clinico comparative study between two different methods of Kala Basti course in the management of Gridhrasi w.s.r. to sciatica – An open labelled randomized trial

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:

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