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 HYPOTHESIS  Diwitiya Baladi Yapana Basti with Trayodashang Guggulu is equally effective as Eranda Muladi Yapana Basti with Trayodashang Guggulu.

ALTERNATE HYPOTHESIS   Dwitiya 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 0 No pain

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

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

GRADE 3 Severe 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 =   [Z_α/2 + Z_β ]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 –

       TOTAL DAYS OF INTERVENTION         08 Days

         FOLLOW UP                                                After 30 Days

        TOTAL DAYS OF STUDY                           38 Days