A comparative clinical study to evaluate the efficacy of Dwitiya Baladi Yapana Basti with Trayodashang Guggulu over Eranda Muladi Yapana Basti with Trayodashang Guggulu in the management of Katigraha (Lumbar spondylosis)

TITLE OF THE STUDY

A comparative clinical study to evaluate the efficacy of Dwitiya Baladi Yapana Basti with Trayodashang Guggulu over Eranda Muladi Yapana Basti with Trayodashang Guggulu in the management of Katigraha (Lumbar spondylosis)

RESEARCH   QUESTION  Is Dwitiya Baladi Yapana Basti  with Trayodashang guggulu more effective than Eranda Muladi Yapana Basti with Trayodashang Guggulu in the management of Katigraha (Lumbar spondylosis) in patients aged 21 to 50 years?

  NULL HYPOTHESISDiwitiya Baladi Yapana Basti with Trayodashang Guggulu is equally effective as Eranda Muladi Yapana Basti with Trayodashang Guggulu.

 ALTERNATE HYPOTHESISDwitiya Baladi Yapana Basti with Trayodashang Guggulu is more effective than Eranda Muladi Yapana Basti with Trayodashang Guggulu.

OBJECTIVES OF RESEARCH PROJECT

PRIMARY OBJECTIVE

To compare the efficacy of Dwitiya Baladi Yapana Basti  with Trayodashang guggulu over Eranda Muladi Yapana Basti with Trayodashang Guggulu in the management of Katigraha based on Oswestry Disability Index.

 SECONDARY OBJECTIVE

To assess the changes in clinical signs & symptoms of Katigraha i.e. Shoola(pain),Stambh(stiffness),Gaurav(heaviness)

To assess the changes in range of motion of lower back in patients with Katigraha

To assess the change in quality of life in patients with Katigraha with Aberdeen LBP Scale

To assess the safety of ayurveda interventions proposed in Katigraha

    A) INCLUSION CRITERIA

 1. patients of any gender of  age between 21-50 years.

2. patients having classical clinical signs and symptoms of katigraha (lumbar spondylosis) with   or without  radiological changes (as per KL scale)

shoola (pain)

stambh (stiffness)

gaurav (heaviness)

3. ODI scale scoring between 5-24.

( mild to moderate cases )

4. Aberdeen LBP scale scoring more than 40

5. Controlled Diabetes mellitus, Hypothyroidism, Hypertension

 ICD 11 code for Lumbar spondylosis - FA8Z

NAMASTE Portal code for Katigraha - SAT-D.1894

   D)EXCLUSION CRITERIA:

 1.    Patients having any other spinal morbidity like- spinal tumor any  other deformities of lumber spine.

2.      Recent lumbar surgery(Less Than 3yr) or implanted instruments or prostheses.

3.      Chronic inflammatory, metabolic or infective pathologies, i.e. Ankylosing spondylitis,  Rheumatoid  arthritis, Psoriatic arthritis, Gouty arthritis, Pott’s spine,  malignancy &/or metastasis in bones.

4.      Patients using NSAIDs & or corticosteroids on regular basis.

5.      Anorectal conditions like Haemorrhoids, Ano-rectal fistulae, Anal fissure, Anal mass etc. those may interfere with Basti chikitsa.

6.      Pregnant or lactating women.

7.      Any other systemic illnesses like IHD, Epilepsy, COPD etc.

8.      Katigraha due to other causes like malignant diseases of the pelvis.

ASSESMENT CRITERIA

1) SUBJECTIVE CRITERIA:

A)Clinical sign and symptoms of Katigraha (Lumabr spondylosis)- Before  treatment and  After treatment:

Shoola (pain)

Stambha (stiffness)

Gaurav (Heaviness)

 a) **SHOOLA (Pain)**By Visual analogue scale.

VAS Scale mentioned in annexure

 GRADE 0No pain

GRADE 1Mild, pain occasionally (1-3 score)

GRADE 2More than mild but tolerable (4-6 score)

GRADE 3Severe pain continuous (7-10 score)

 b)     STAMBH (Stiffness):

GRADE0  Absent

GRADE 1: Mild, occasionally GRADE 2: Moderate, for 30-1 hr daily GRADE 3: Severe, persistent

 c)      GAURAV (Heaviness): GRADE 0: Absent

GRADE 1: Mild, occasionally for 10-30 min

GRADE 2: Moderate for 30-1 hr

GRADE 3: Severe persistence More Than 1 hr

B) OSWESTRY  DISABILITY INDEX

(QUESTIONNAIRE FOR    PATIENTS)

                C) ABERDEEN LBP SCALE

Mentioned in annexure

2)  OBJECTIVE CRITERIA:

 A) RANGE OF MOTION: RoM will be measured with the help of Goniometry.

Flexion -Normal flexion is 900

Extension-Normal extension is 300

Lateral Flexion (Rt And Lt) -Normal lateral flexion is 300 on each side

Rotation – Normal rotation is 300 at both sides

KL –for screening only

 SAMPLE SIZE-

 The calculated sample size is estimated to be around 36 in each group, assuming 10% drop outs, we shall be enrolling 40 patients in each group.                                                   n =   [Zα/2 + Zβ ]2                                                        12c(1-c)(pn-0.5)2                                                              pn = probability that a score from x is larger than a score from y is larger than 1/2              c = 1/(1+k) where k = allocation ratio calculated sample size=40 in each group

Due to time and budget constraints the total sample size will be taken as 60 (30 in each group).

GROUPING –

Intervention

GROUP A

Control Group

GROUP B

Trial Group

|Abhyantar Chikitsa

Trayodashang Guggulu 500mg BD B/F

Trayodashang Guggulu 500mg BD B/F

|Sarvang abhyanga

Dhanvantar Tailam,

Dhanvantar Tailam,

|Sarvang Bashpa swedan

Dashmoola Kwatha.

Dashmoola Kwatha.

|Anuvasan Basti

Dhanvantar Tailam.

Dhanvantar Tailam.

|Niruha Basti (Yog Basti krama)

Eranda Muladi Yapana Basti 660ml

 Dwitiya Baladi Yapana Basti 660ml

Basti

Anuvasan

Niruha

Anuvasan

Niruha

Anuvasan

Niruha

Anuvasan

Anuvasan

|Day

1st  day

2nd day

 3rd  day

4th day

5th day

6th day

7th day

8th day

 TOTAL DAYS OF INTERVENTION         08 Days

FOLLOW UP                                                After 30 Days

TOTAL DAYS OF STUDY                           38 Days