To Compare The Efficacy Of Devdarubaladi Taila And Balasaireyaka Taila For Matra Basti In The Management Of Janu Sandhigatavata Osteoarthritis Of Knee Joint An Open Labelled Randomized Clinical Trial

RESEARCH QUESTION :

Is there any significant difference in the efficacy of Devdarubaladi Taila Matra Basti and Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata (Osteoarthritis of knee joint)?

 HYPOTHESIS:

NULL HYPOTHESIS(H0*): Devdarubaladi Taila Matra Basti* and Balasaireyaka Taila Matra Basti has same effect in management of Janu Sandhigata Vata(Osteoarthritis of knee joint).

ALTERNATIVE HYPOTHESIS (H1): Devdarubaladi Taila Matra Basti is more effective than Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata(Osteoarthritis of knee joint).

ALTERNATIVE HYPOTHESIS (H2): Devdarubaladi Taila Matra Basti is less effective than Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata(Osteoarthritis of knee joint).

 AIM:

To evaluate and compare the efficacy of Devdarubaladi Taila Matra BastiandBalasairayaka Taila Matra Basti in the management of Janu Sandhigata Vata (osteoarthritis of knee joint).

 OBJECTIVES:

Ø  To study the etiopathogenesis of Janu Sandhigata Vata according to Ayurveda as well as Modern aspect.

Ø  To study Matra Basti according to all Ayurvedic texts.

Ø  To study the effect of Devdarubaladi Taila Matra Basti and Balasaireyaka Taila Matra Bastiin the management of Janu Sandhigata Vata (osteoarthritis of knee joint).

Ø  To compare the effect of Devdarubaladi Taila Matra Basti and Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata(osteoarthritis of knee joint).

 DIAGNOSTIC CRITERIA:

• SUBJECTIVE CRITERIA:

Patients having classical signs and symptoms of the Sandhigata Vataaccording to Ayurveda as well as Modern science will be taken into consideration.

Ø  Vatpurna Druti Sparsh,

Ø  Shotha (joint swelling)

Ø  Akunchan Prasarne vedana,

Ø  Sandhi Shoola (joint pain),

Ø  Joint Stiffness

Ø  Crepitus.

ʉۢ OBJECTIVE CRITERIA :

Ø  Patient with radiological features suggestive of Osteoarthritis of knee joint like reduction of Joint space, Osteophytes formation, Loose bodies, Osteoporosis.

CRITERIA FOR SELECTION OF PATIENT: Patient will be selected irrespective of caste, gender, profession etc. from O.P.D. and I.P.D. of Govt. Akhandanand Ayurveda Hospital, Ahmedabad and Govt. Maniben Ayurveda Hospital, Ahmedabad.

INCLUSION CRITERIA:

Ø  Patients presenting with the classical signs and symptoms of Sandhigata Vata (OA) according to Ayurveda as well as Modern science.

Ø  Patients of age ≥40 to ≤70 years.

Ø  Patient is indicated for Snehanaand Swedana.[i]

Ø  Patients indicated for Basti Karma.

EXCLUSION CRITERIA:

Ø Patients ≤ 40 years and ≥ 70 years of age.

Ø Known cases of Gout, Rheumatoid Arthritis, Systemic Lupus Erythematous (SLE), Bone TB, Traumatic injuries, Infective arthritis and other serious systemic disorder.

Ø Patient is not indicated for Snehana and Swedana.

Ø Patient is unfit for Matra Basti (eg*. Raktarsha , Bhagandar* etc.)

Ø Patient having history of knee joint replacement.

   STUDY DESIGN:

Ø STUDY TYPE      : Open Labelled Randomized Clinico Comparative Trail

Ø BLINDING            : Open label

Ø COMPARATIVE  : Yes

Ø NO. OF GROUP : 2

GROUP-1: Will be treated with Devdarubaladi Taila Matra Basti.

GROUP-2: Will be treatd with Balasaireyaka Taila Matra Basti.

Ø SAMPLE SIZE     : Minimum 15 patients will  be  include  in each group.

Ø LOCATION OF STUDY : Study will be conducted at Government Akhandanand  Ayurved Hospital ,Ahmedabad and Maniben Ayurved Hospital.

 The patients will be randomly divided into two groups irrespective of their Age, Gender, Religion and Occupation.

Group-A : Devdarubaladi Taila Matra Basti for 15 days.

Group-B: Balasaireyaka Taila Matra Basti for 15 days.

INVESTIGATIONS:

Ø  Haematological examination: HB%, CBC(Both B.T. and A.T.), ESR

Ø  RBS, RA, Uric Acid (To rule out other pathologies).

Ø  Radiological Assessment: Plain X-ray AP and Lateral view- standing position (Both B.T. and A.T.).

 WITHDRAWAL CRITERIA:

After the scheduled course, medicines will be withdrawan  with proper consultation and future follow up will be maintained. During the trail period, if any moderate to severe complications found, medication will be stopped.

CRITERIA FOR ASSESSMENT:

Ø By observing clinical improvement in signs and symptoms of disease mentioned in Ayurvedic classics as well as modern texts.

Ø To assess the effect of therapy objectively, all the signs and symptoms like Sandhishula, Sandhishotha , Akunchan prasarne Vedana,  Sandhisphutuna (Crepitation) will be subjected to given scoring patterns.

Ø Assessment will be done before treatment and after completion of entire treatment.

 REPORTING A.D.R:

Adverse Drug Reaction (ADR), if observed will be registered and reported to Peripheral Pharmacovigilance Center (PPvC), GAAC, Ahemdabad.

 STATISTICAL ANALYSIS:

Assessment will be done on the basis of special proforma through scoring pattern and will be analysed statistically with help of “t” test and Willcoxon signed-rank test. where > 0.05=insignificant result, < 0.05 = significant result and < 0.001= highly significant result.

STANDARD PROFORMA:

Standard proforma will be developed and used in the study to evaluate the comparative efficacy of the trail drug.

PRESENTATION OF DATA: The data collected, analysed will be depicted as general observations viz. age, sex, religion etc. The results of individual investigations will be presented by a proper bar diagram, pie diagram etc.

DISCUSSTION AND CONCLUSION:

After getting all the data, discussion and conclusion will be done as per the observations and results.

COLLABORATION REQUIRED: With other Department

Department of RSBK, Dravyaguna and Roganidan-Vikruti Vigyan Department Government Akhandanad  Ayurved Collage, Ahmedabad.

DECLARATION: The study will be completed in the stipulated time limit. The work will be carried out after getting clearance from the institutional ethics committee. The data related to the identification of the patient will be kept confidential. The clinical data obtained will be summarized at the end of the study.