A Randomised Comparative Clinical Study To Evaluate The Efficacy Of Doshghna Lepa And Modified Doshghna Patch As An Adjuvant Therapy In The Management Of Amavata W.S.R.To Rheumatoid Arthritis

INTRODUCTION: In our classics, under Sthanika Chikitsa and Sarvadaihika Chikitsa different modalities of treatment have been explained for the management of Amavata. In Sthanaika Chikitsa mainly the Kalpana’s which are going to reduce the uneasiness of affected part are explained and Lepa Kalpana is one among them. Lepa Kalpana is a type of Kalka Kalpana. Amavata (Rhematoid arthritis) is one among systemic disorder, which affects the locomotor system resulting severe tenderness and inflammation in affected joints. To overcome from the tenderness and inflammation the topical applications like Lepa (topical applications) are explained which may help in the remission of symptoms instantly and may also act as local analgesics.

  NEED OF STUDY. Lepa kalpana is one of the upakalpana mentioned in Ayurveda for external application of the body surface.Lepa in its textual form is not convenient in the present era.

Nowadays it is difficult to use lepa in its actual form because of smell, greasiness, fluidity and due to lack of time. In the present era there is a demand for potent, easy, fast formulations. Hence, research on modifications of lepa kalpana is being undertaken in Ayurveda for increasing its efficacy and shelf-life.Hence the shelf life depends upon the base with which the drugs are mixed to form a lepa. In these new Ayurvedic patch herbs are the main ingredients and these herbs are added with some base for the patch. To mitigate target dose methodology, the patch is more beneficial than the lepa Kalpana.

PREVIOUS WORKDONE:

·       Patel P, Kumar P. patch: Recent approaches for the effective treatment of Rheumatoid Arthritis.

·       Modulation of agnilepa in the management of Amavata*,* Dr.Divya.B ,Ph. D scholar, Department of Panchakarma a, Parul Institute of Ayurved, Parul University, Vadodara, Gujarat.

·       yoshitha c n., Ph.D Scholar, all institute of ayurveda : development of an innovative patch and evaluation of its comparative clinical efficacy in knee osteoarthritis.

   RESEARCH QUESTION:

Whether modified Doshghna patch equally effective to Doshghna lepa in management of Amavata?

 AIM: To Develop the doshghna patch and Evaluation of its comparative clinical efficacy With Doshghna lepa in Amavata.

  OBJECTIVES:

To Develop the modified Doshghna patch.

To study the efficacy of Doshghna lepa in the management of Amavata.

To study the efficacy of modified Doshghna patch in the management of Amavata.

To compare the efficacy of Doshghna lepa and modified Doshghna patch in the management of Amavata

  HYPOTHESIS:

Null hypothesis (H0) –Doshghna lepa and modified Doshghna patch are not equally effective in the management of Amavata.

Alternate Hypothesis: (H1) – A Doshghna lepa is more effective than modified Doshghna patch in the management of Amavata.

(H2) – A modified Doshghna patch is more effective than Doshghna lepa in the management of Amavata.

(H3) - Both Doshghna lepa and modified Doshghna patch are equally effective in the management of Amavata.

  METHODOLOGY:

Study will be divided in two phases:

Phase 1: Analytical and Pharmaceutical Test

Phase 2: Clinical Trial

Group A - 20 patients will be taken for Doshghna lepa in the Management of Amavata.

Group B-20 patients will be taken for Modified Doshghna patch in the Management of Amavata.

 MATERIALS AND METHODS

SOURCES OF DATA:

(a)Literary source – All classical, modern literature and contemporary texts including the journals and websites about the disease, drug and procedure will be reviewed and documented for the study.

(b) Pharmaceutical source – All the required drugs will be well identified and collected from local vendors and patch will be prepared in teaching Pharmacy of Parul institute of ayurveda and research, as per proper SOPs.

(c) Clinical Source – Diagnosed cases of Amavata will be selected from OPD and IPD of Parul Ayurved Hospital, Limda, Vadodara, Khemdas Ayurved Hospital, Limda, Vadodara, Parul Sevashram Hospital, Vadodara, and special campaigns fulfilling the criteria of selection and who are willing to participate in the present study will be included for the clinical study.

 STUDY DESIGN – Randomised Comparative Clinical Study.

 DIAGNOSTIC CRITERIA

• American Rheumatism Association (A.R.A.) Criteria for Diagnosis • Rheumatoid arthritis is defined by the presence of 4 or more criteria,

1. Morning stiffness (>one hour)

2. Arthritis three or more joints area

3. Arthritis of hand joints

4. Symmetrical arthritis

5. Rheumatoid nodules

6. Presence of Rheumatoid factor

7. Radiological changes (hand & wrist)

 STUDY DURATION: 18 Months

 ASSESSEMENT CRITERIA

(a)SUBJECTIVE CRITERIA The classification criteria for rheumatoid arthritis are a score-based algorithm. Assessment of the effect of treatment will be done with following parameters:

➢ Severity grading with percentages 0-4

• Grading of Stiffness present in joint 0-4

• Grading of Swelling present in joint 0-4

• Grading of Movement 0-4

• Grading of Tenderness present in joint 0-4

 (b)OBJECTIVE CRITERIA

• ESR

• RA factor

• Range of Movement measured with the help of Goniometer (shoulder, elbow knee, ankle)

 INTERVENTION:

• Duration of treatment -7 days

• Follow up after 7 days of treatment.

• 20 patients were selected. Doshghna Lepa of sufficient quantity (15 gm) will be applied externally Twice a day for 7 days.

• 20 Patients selected for Doshghana patch will be applied externally.