A single arm prospective phase ii clinical study to evaluate the effect of chaturbeej jelly candy (as a neutraceutical product) on abdominal pain in kashtartava w.s.r to primary dysmenorrhea in young girls

Changinglifestyle and changed diet pattern is causing many harmful effects on health.Such effects are seen on the female reproductive system also. Primary dysmenorrhea is one of the mostcommonly found condition in adolescent girls. Many treatments are available forthis condition. But these medicines are also having side effects. Secondlyyoung girls refuse to take medication for this as they have to take it everymonth. Due to this there is effect on their daily routine. Hence to overcomethis situation Herbal jelly candy will be prepared using Chaturbeej, organicjaggery and Pectin.

Sincethis is a new and attractive dosage form adolescent girls are expected to havemore acceptance to this. The main outcome of this is relief in abdominal paincaused due to primary dysmenorrhea. 150 subjects willbe selected using simple random sampling method. After screening and consentthey will be included in the study following proper inclusion and exclusioncriteria. The Herbal jell candy which is a neutraceutical product will be giventhrice a day. Each weighing 2gm and containing 1gmof Chaturbeej. The duration will be for 3 days during menstruation.

Abdominalpain will be measured for intensity, duration and nature of pain. VAS will beused to rate the pain. This will be assessed daily i.e. for three days. Overallsafety will be assessed based on safety parameter. Quality of life of theadolescent girls who have taken these herbal candy will be assessed.

Theterm “Kashtartava” means a condition where in Artava is shed with pain. Kashtartavacan be  compared with primarydysmenorrhea based on the symptoms. Kashtartava is a vata and kapha pradhanvyadhi with mainly predominance of vata dosha. Due to kapha prakopa, kaphaobstructs the srotas and this leads to the dosha prakopa along with pratilomagati of apana vayu leading to rajakrichrita . Kashtartava is one of theartavavaha srotodusti vyadhi in which pain during menstruation is thepredominant feature.

Todaydue to changed lifestyle and dietary habits adolescent girls are mainly facingthis problem of abdominal discomfort or pain. And for this they need to takemedication every month during menstruation. But these analgesics andantispasmodics are having severe side effects on the health of young girls.They also sometimes refuse to take medicines and hence leaving with such paincan hamper their daily routine, my it be going to school or colleges or otherroutine work. Those girls involved in sports face this as a major hurdle.

Henceto overcome this issue Herbal jelly candy is an innovative option. These jellycandies can be made from the drugs which are vatanulomak and vedanashamak.Pectine can be used as a base for making these jelly candy and organic jaggerywill be used as sweetener. The jelly candy are a chewable sweet which will becontaining herbs useful in relieving abdominal pain in Kashtartava. Thesecandies can be made available in attractive packaging. Since the dosage form ofthe medicine is interesting it can be easily accepted and consumed by thepatients. Secondly they are cost effective as compared to the medicinesavailable for the same condition in the market .Chaturbeej is mentioned in Bhavaprakash for abdominalpain. But in this study it will be specifically used in abdominal painexperienced in Primary dysmennorrhoea. The dosage form mentioned in theclassical texts is churn (powder ) form. But in this study jelly candy will beprepared using Chaturbeej churn.

This Chaturbeej jelly candy will be prepared usingPectin , which is a plant extract and mainly derived from citrus fruits. Hencethis is not harmful. There are studies which suggest that pectin is supposed tohave good effects on digestive system. It is also helpful in constipation whichmay persist during Primary dysmennorrhoea.

Chaturbeej jelly candy is a new and innovativepalatable dosage form. Jaggery will be added as a sweetener . This will alsohelp in improving the action of Chaturbeej there by leading to vatanuloman. Dueto the sweet taste it will be easily consumed by young girls.

Chaturbeej contains four drugs which are available inthe Indian kitchen and is used  in daytoday food prepared at home. Hence this is a neutraceutical option forabdominal pain without any side effects on body.

Chaturbeej is mentioned in Bhavaprakash for abdominalpain. But in this study it will be specifically used in abdominal painexperienced in Primary dysmennorrhoea. The dosage form mentioned in theclassical texts is churn (powder ) form. But in this study jelly candy will beprepared using Chaturbeej churn.

This Chaturbeej jelly candy will be prepared usingPectin , which is a plant extract and mainly derived from citrus fruits. Hencethis is not harmful. There are studies which suggest that pectin is supposed tohave good effects on digestive system. It is also helpful in constipation whichmay persist during Primary dysmennorrhoea.

Chaturbeej jelly candy is a new and innovativepalatable dosage form. Jaggery will be added as a sweetener . This will alsohelp in improving the action of Chaturbeej there by leading to vatanuloman. Dueto the sweet taste it will be easily consumed by young girls.

Chaturbeej contains four drugs which are available inthe Indian kitchen and is used  in daytoday food prepared at home. Hence this is a neutraceutical option forabdominal pain without any side effects on body.