An open label single arm clinical trial to evaluate the safety and efficacy of NEEMINT capsules in management of gastrointestinal disorders including irritable bowel syndrome.

Irritable bowel syndrome (IBS) is a common disorder that affects the large intestine. Signs and symptoms include cramping, abdominal pain, bloating, gas, and diarrhea or constipation, or both. IBS is a mix of belly discomfort or pain and trouble with bowel habits: either going more or less often than normal (diarrhea or constipation) or having a different kind of stool (thin, hard, or soft and liquid).

There are four types of the condition:

·       IBS with constipation (IBS-C)

·       IBS with diarrhea (IBS-D)

·       Mixed IBS (IBS-M) alternates between constipation and diarrhea

·       Unsubtyped IBS (IBS-U) for people who don’t fit into the above types

IBS isn’t life-threatening, and it doesn’t make you more likely to get other colon conditions, such as ulcerative colitis, Crohn’s disease, or colon cancer. Anti spasmodic, Anti diarrheal, proton pump inhibitors are a few of the remedies which one usually adopts, but it is however not natural and can cause side effects.

NEEMINT capsule is a blended formulation of neem and peppermint oil, which both together can relieve symptoms of gastrointestinal disorders including Irritable bowel syndrome.

 Neem oil

Neem oil extracted from the neem plant is said to be extremely beneficial for health. The extract from the neem bark has powerful properties to cure these ailments safely. This usually happens because Neem increases the quantity of gastric mucus which plays a major role in combating ulcers. Neem is considered a useful therapy for ulcers and gastric discomfort.  Compounds in neem have been proven to have ant ulcerative effects.  Peptic ulcers and duodenal ulcers are treated well with neem leaf extracts; nimbidin from seed extracts taken orally prevents duodenal lesions and peptic ulcers, and provides significant reductions in acid output and gastric fluid activity.

Neem is also useful in treating other problems in the stomach and bowels.  The herb promotes a healthy digestive system by protecting the stomach, aiding in elimination, and removing toxins and noxious bacteria.  Its leaves are often used to treat heartburn and indigestion.  Some neem extracts reduce the concentration of hydrochloric acid in the stomach.

Neem extracts are also used to treat gastritis.  The extracts reduce the amount of acid in the stomach; their antibacterial and anti-inflammatory properties can relieve the effects of this condition. Neem has also been shown to be effective for treating digestive disorders such as diarrhea, dysentery, hyperacidity and constipation. For diarrhoea and constipation also neem is found to be effective.

Peppermint oil

Peppermint oil is an aromatic herb extracted from peppermint plant. It is used to treat Irritable bowel syndrome and other digestive issues.

  Contraindications

Peppermint oil is relatively contraindicated in patients with hiatal hernia or significant gastroesophageal reflux disease, because its effect on the lower esophageal sphincter can lead to exacerbation of symptoms. Peppermint oil has been used to trigger menstruation and should be avoided during pregnancy.

Warnings and Precautions

1. Neemint capsules are likely unsafe when taken by mouth during pregnancy. They can cause a miscarriage.

2. Neem might lower blood sugar levels. There is a concern that it might interfere with blood sugar control during and after surgery. Stop using neem at least 2 weeks before a scheduled surgery.

Side effects and adverse reactions

1. Peppermint can cause some side effects including heartburn, and allergic reactions including flushing, headache, and mouth sores.

2. When neem is taken by mouth in large doses or for long periods of time ,it might harm the kidneys and liver.

 Rationale for the study:

·      This study is proposed to evaluate the efficacy and safety of test product NEEMINT Capsules to prevent gastrointestinal disorders including irritable bowel syndrome.