1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [Priyankasahare13.ps@gmail.com].
   


6. For how long will this data be available start date provided 25-09-2020 and end date provided 25-12-2021?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

Ayurveda is an ancient Indian holistic medical science which deals with body, mind, Spirit and aims at preservation-promotion of health and prevention-cure of diseases. It emphasises on the importance of healthy food habits and regimens, which is responsible for preservation of health. It is based on the concept of Dosha, Dhatu, Mala, Panchmahabhuta, Tanmatra, Agni and Srotas. The body contains numerous channels through which Dhatu, Dosha and Mala circulate known as Srotas. Person is the only aggregate of Srotas because of their pervasiveness and diffusiveness of agents aggravating and pacifying Doshas.

 Srotas are the channels or pores which provide nourishment to the whole body and responsible for particular function with respect to specific body parts. Srotas not only perform various functions but disturbance in Srotas may also impart some pathological manifestation.  Srotas are defined as transporting passages of Dhatus undergoing transformation. There are 13 types of Srotas described in Ayurveda.

Mamsavaha Srotas is one among them. It can be traced to the ligaments, skin and blood carrying Dhamanis. Their injury leads to swelling, atrophy of muscles, varicosity of veins and death. Mamsavaha Srotas are affected when person takes channel blocking, bulky and heavy food and also sleep during the day.

Galaganda is defined as a swelling in the neck or small hanging like the scrotum. Vata and Kapha undergoing increase bring about changes in Medas (fat) and produce swelling in the neck and its sides.

Thyroid gland is one of the largest gland of the endocrine glands. It is composed of large number of closed follicles. These follicles are lined with cuboidal epithelium cells known as follicular cells. Follicular cells secrete two major hormones, Triiodothyronine (T₃) and Tetraiodothyronine (T₄ or thyroxine) respectively. Both of these hormones are iodine-containing derivative of amino acid tyrosine. Thyroid secretion is primarily controlled by Thyroid stimulating hormone (TSH).

 Irregular secretion of Thyroid hormone results in –

·      Hypothyroidism

·      Hyperthyroidism

Goiter is a swelling in the neck resulting from an enlarged thyroid gland. It occurs both in hypothyroidism and hyperthyroidism. Endemic colloid goiter is due to hypothyroidism which is caused by iodine deficiency. It is also called iodine deficiency goiter. It is caused when iodine intake is less than 50 µg/day.

Shigru (Moringa oleifera) has Katu, Tikta Rasa; Laghu, Ruksha, Tikshna Guna; Ushna Virya and Katu Vipaka. It is having Kaphavataghna Properties. Major chemical constituents of leaves of Shigru include amino acid viz. arginine, serine, tyrosine, aspartic and glutamic acid, glycine etc.

NEED OF STUDY

Iodine deficiency is a major nutrition problem in India. The World Health Organisation (WHO) estimates that about 2 billion people are iodine deficient. In areas of relative iodine deficiency, there is an increased prevalence of goiter. In hypothyroidism, the endemic colloid goiter is caused due to iodine deficiency. Acharya Charak in Vimansthan 5^th chapter stated that in morbidity of the Srotas for Rasa, Rakta, Mamsa, Meda, Asthi, Majja and Shukra, the treatment should based on various food and drink application. Shigru (Moringa oleifera) is the most widely cultivated species in India. Major chemical constituents of leaves of Shigru include amino acid viz. arginine, Serine, tyrosine, aspartic and glutamic acid, glycine etc., which is most effective in goiter. Management of goiter with the modern drugs may bring the value of Thyroid hormones to normal range but the increased dosage and continuous medication are cost expensive and make the patient into drug dependent till the end of mortal life. So for a better, safer and long lasting therapy is needed for the present society and now it is a demand of time to search the management for this type of ailment through Ayurveda.

                                         Hence, this study will be done to evaluate the efficacy of Shigru Patra Churna in Galaganda (goiter).