EFFICACY OF ORAL ADMINISTRATION OF SHATAPUSHPA CHURNA WITH GOGHRITA IN THE MANAGEMENT OF KSHEENA ARTAVADUSHTI AN EXPLORATORY CLINICAL STUDY

TITLE Efficacy of oral administration of Shatapushpa Churna with Goghrita in Management of Ksheena Artavadushti : An Exploratory Clinical Study

  Research Question- What is the effect of Shatapushpa Churna15g  with Goghrita in management of Ksheena Artavadushti

NULL HYPOTHESIS-  Oral administration of Shatapushpa Churna15g with Goghrita is not effective in the management of Ksheena Artavadushti.

ALTERNATE HYPOTHESIS- Oral administration of Shatapushpa Churna 15g with Goghrita is effective in the management of Ksheena Artavadushti.

 Introduction

         Stree is the root cause of progeny and thus she should be protected from any ailments that can affect her motherhood. The Menstrual cycle is the hormonal process a woman’s body goes through each month to prepare for a possible pregnancy.  It is the visible manifestation of cyclic physiological uterine bleeding due to shedding of the endometrium following the invisible interplay of hormones via the Hypothalamo-pituitary-ovarian axis. For Normal menstruation to occur, the axis must be coordinated and Endometrium must be responsive to the hormones and genital tract should be patent. Any deviation in the physiological cyclic bleeding can prove to be a significant issue and a matter of concern to the woman.

Nowadays the changing lifestyle changing food habits  junk food Stressful and busy schedule environmental pollutants can trigger an imbalance in the normal functioning of the Hormonal axis to cause Irregularities in the menstrual cycle. Oligomenorrhea is one of the most common types of menstrual bleeding disorders with its prevalence ranging from 12percent to 15.3percent worldwide. Oligomenorrhea is defined as the Irregular and inconsistent menstrual blood flow in a woman. If interval between two menstrual cycles is greater than 35 days or four to nine menstrual cycles in a year then it is termed as Oligomenorrhea. Oligomenorrhea is usually associated with anovulation and can impair the fertility in the long run if untreated. Also it can lead to growth of estrogen dependent tumors due to uninhibited action of Estrogen.

Ksheena Artavadushti can be correlated with Oligomenorrhea Hypomenorrhea Dysmenorrhea and upto a certain extent with Secondary Amenorrhea. Ksheena artava is described in classical texts as deficiency or loss of Artava or Menstruation not occurring at the appropriate or expected time. There are multiple etiologies of Oligomenorrhea of which Polycystic Ovarian Syndrome accounts for 4 to10percent.

NEED OF STUDY

According to contemporary medicine, the management of Oligomenorrhea is done commonly with the use of Oral Contraceptive Pills in patients who are not desirous of pregnancy. In patients with anovulation and desirous of pregnancy use of drugs like Clomiphene Citrate or Letrozole is done for induction of Ovulation. But the side effects of combined OCP can range from weight gain vomiting mastalgia hypomenorrhea amenorrhea leucorrhea to even aggravation of hypertension thromboembolism and neoplasms. Long term use of OCP can lead to dependency on hormones and unresponsiveness of endometrium. And due to the various side effects compliance of patients also reduces towards the treatment regime.

The long term complications of untreated Oligomenorrhea include

Infertility

Endometrial Hyperplasia

Endometrial cancer   Osteoporosis

Cardiovascular problems

Neuropsychiatric complications

 Ayurveda being the holistic science can provide promising result in this case. In this aspect we are administering Shatapushpa churna Orally with Goghrita. The Use of Shatapushpa with Goghrita can promise good results. Oral route of administration can also promise better patient compliance and continuation of treatment regime. Previous work done on Shatapushpa has shown promising results in reduction of symptoms like irregularity of menstruation pain during menstruation. As Shatapushpa has been mentioned to be Artavajanaka, Putraprada and Vatashamaka, its action in induction of ovulation with regulating menstrual cycle will be observed in the study.

AIMS AND OBJECTIVES-

To understand the etiopathogenesis of Ksheena artavadushti through Ayurveda and Contemporary Science.

To Evaluate the efficacy of oral administration of Shatapushpa Churna with Goghrita in managing the Ksheena Artavadushti and Explore the effects of Shatapushpa by observing changes in the Hormonal Assay and its effects on anovulation.

 MATERIALS AND METHODS

  Step1 Conceptual study- the detailed study of Ksheena Artavadushti and Oligomenorrhea.

Step 2A detailed review of drug will be done.

Procurement of drug- The drug will be procured from a GMP certified company or it will be

prepared in the RSBK department of AIIA Saritavihar.

Goghrita will be procured of a standard Amul Company. Amount of Goghrita will be measured and administered to the patient.

Authentication and standardisation –Authentication and standardisation of formulation will be done as per standardised norms.

Step 3Therapeutic intervention.

 STUDY DESIGN-EXPLORATORY

STUDY TYPE- INTERVENTIONAL

PURPOSE-TREATMENT

TIMING-PROSPECTIVE

SAMPLE SIZE-47 AS PER FORMULA

DUE TO TIME AND BUDGET CONSTRAINT SAMPLE SIZE WILL BE KEPT AS 25.

NO. OF GROUPS-01

END POINT- EFFICACY AND SAFETY

STUDY SETTING- OPD of Prasuti Tantra Evum Stri Roga, All India Institute Of Ayurveda

Number of Groups- 1

Source Of Data- Literary Source will be collected from

1.Library

2.Relevant Articles

 SAMPLE SIZE AND CALCULATION

The study aims to assess the role of Shatapushpa Churna with Goghrita on Ksheena Artavadushti.The studies done earlier on other treatment regimen have shown variable effectiveness in the range of 40 to 60 percent in improving this condition partially/moderately or fully. It is assumed that probability of improvement maybe in the range of 75percent. Assuming power of the test as 80percent , level of significance as 5percent, two sided test, the calculated sample size is 42 and with 10percent dropout is 47 in this study. Due to budget and time constraint the sample size will be kept as 25.

•        Non Parametric: One Group Wilkoxon Signed Ranks Test

•        Assumptions-

•        The observations are paired and independently distributed.

•        The variable under study is continuous.

INCLUSION CRITERIA

Married female patients between the age of 20 to 40yrs  willing to participate.

Increased interval between 2 cycles of more than 35days  to 56 days with scanty or normal flow.

 EXCLUSION CRITERIA

Anatomical defects of genital tract  Primary Amenorrhea.

Thyroid Dysfunction  Asthma  Autoimmune conditions Systemic disorders like DM  HTN  TB.

Menorrhagia  Endometriosis Uterine Fibroids  Uterine Polyps and Carcinoma.

Patients taking Antiepileptics  Antipsychotics and Oral contraceptive pills.

 Assessment criteria-

Subjective parameters-

Duration Of Bleeding

Interval between two cycles

Flow during menstruation

Pain during menstruation

Investigations- to be done at 2 levels

Before Treatment

After Treatment

 CBC,LFT,Lipid Profile, HbA1c

Sr TSH

Sr FSH on Day 3

Sr LH on Day 3

Sr Estradiol on Day 3

Sr Progesteron on Day 21

Sr PRL

TVS FOR FOLLICULAR STUDY