A randomised controlled clinical study to evaluate the efficacy of virechana karma and sushrutokta trividha basti with varunadi kashaya in the management of hypothyrodism

Hypothyroidism is one among the endocrinal disorder. Thyroid is an endocrinal gland secrets T3 and T4 hormones regulated by TSH which is secreted by Pituitary gland. The prevalence of hypothyroidism in India is 11%. To date, no proper curative measures are found to treat hypothyrodism in modern science, so it is necessary to find a safe and effective measure for hypothyrodism.Hypothyroidism is a autoimmune disorder which is correlated with dhatu agni mandya and lena dosha avastha. In this study Sushrutokta Trivdh Basti can help in utkleshan of lean dosha there after their sodhan and shaman. So an attempt is made to study the efficacy of Shushrutokta Trivdh Basti in this condition. Virechana is the best therapy for the Pitta, Pitta associated with Kapha or Vata, and for Dosha situated in Pittasthana. Hypothyroidism refers to the underactivity of thyroid gland resulting into deficiency of thyroid hormones which may be considered as malfunctioning of Agni (Pitta). Virechana is the best treatment for the regulation of Pitta Dosha and agni. So an attempt is made to study the efficacy of Shushrutokta Trivdh Basti and Virechan Karma With Varunadi Kashaya in the management of Hypothyrodism.

RESEARCH QUESTION:

Is Virechana Karma and Sushrutokta trividha basti followed by Shamana (Varunadi Kashaya) effective in the management of Hypothyrodism?

AIM:

TO EVALUATE THE EFFICACY OF VIRECHANA AND SUSHRUTOKT TRIVIDHA BASTI AND VARUNADI KASHAYA IN THE MANAGEMENT OF HYPOTHYRODISM

OBJECTIVES:

1. To Study the effect of Virechan Karma in the management of Hypothyroidism

2. To Study the effect of Sushrutokt Trividha Basti and observe its effect in the management of Hypothyrodism

3. To Study the effect of Varunadi Kashaya in the management of Hypothyroidism

MATERIAL AND METHODS:

DURATION OF STUDY: 18 Months

STUDY DESIGN: Randomised comparative clinical trial

Purpose of the study will be explained and written informed consent will be taken from every patients.

Source of data

1. LITERARY SOURCE: All the available literature regarding Virechan Karma and Sushrutokta trividha basti and varunadi kashay in classical and contemporary texts including journals and online sources will be reviewed and documented for the study.
2. PHARMACEUTICAL SOURCE : Medicine will be prepared in the GMP Certified pharmacy.
3. CLINICAL SOURCE : Diagnosed cases of Hypothyroidism, will be selected from OPD and IPD of Parul 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.

TREATMENT GROUPS:

GROUP A (Trial Group) - 20 Patients will be administered Sushrutokta Trividha Basti by Shamana (Varunadi Kashaya).

GROUP B (Control Group) - 20 Patients  will be administered Virechana Karma followed by Shamana (Varunadi Kashaya).

SUBJECTIVE CRITERIA:

Symptoms:

Tiredness,Weakness

Dry Skin

Feeling colds

Hair Loss

Difficulty in concentrating and poor memory

Constipation

Weight gain with poor appetite

Hoarse voice

Menorrhagia

Paraesthesia

Dyspnoea

Impaired hearing

Signs:

Dry Coarse Skin

Cool peripheral extremities

Puffy face

Diffused alopecia

Bradycardia

Peripheral Oedema

Delayed tendon reflex

Carpel tunnel syndrome

OBJECTIVE CRITERIA:

T3

T4

TSH

INTERVENTION:

Sushrutokta Trividh Basti (in Chaturbhadra Kalpa Basti pattern):

Chaturbhadra Kalpa Basti: 12 days

1st day 2nd day 3rd day 4th day 5th day 6th day 7th day 8th day 9th day 10th day 11th day 12th day
AB AB AB AB NB NB NB NB KB KB KB KB

Here,

AB - Anuvasana Basti

NB - Niruha Basti

KB - Ksheer Basti

Basti Quantity

1. Anuvasan Basti - 240 ml
2. Niruh Basti - 1164 ml
3. Ksheer Basti - 582 ml

Follow up -

Before Treatment (Day- 1)

After Treatment (Day-13)

After One Month (Day-30)

The effect of the Basti (Panchakarma therapy) will be assessed based on the following criteria –

Samyak Basti Lakshanas

The retention time of Basti

Number of purisha vega

Possible complications after administration of Basti

Vital data of patients

Intervention Of Virechan Karma:

Deepana-Pachana  Snehpana  Vishram Kala  Virechana Karma Samsarjan Karma
Aampachak Vati  Chitrakadi Vati Moorchita Tila Taila Abhyanga and Swedana Trivrit LehyamPeya, Vilepi, Akritkrityush, Akritkritmamshrash
3 to 4 days 5 to 7 days (Till Samyak Snigdha Lakshna Achieved) 3 days After 3 days of Vishram Kala As Per Suddhi