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CTRI Number  CTRI/2021/04/032735 [Registered on: 12/04/2021] Trial Registered Prospectively
Last Modified On: 20/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study the effectiveness and safety of NEEMINT capsules in management of gastrointestinal disorders including Irritable bowel syndrome 
Scientific Title of Study   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. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PHAR/2021/NG/04, Version 1.0 dated 13 March 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Giriraja KV 
Designation  Principal Investigator 
Affiliation  Consultant- General Medicine 
Address  Department of General Medicine, Rajalakshmi Hospital, Lakshmipura Main Road, Vidyaranyapura Post,Bangalore-560097 Bangalore KARNATAKA

Bangalore
KARNATAKA
560097
India 
Phone    
Fax    
Email  drgirirajkv@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Baburao Vikram 
Designation  Directortor 
Affiliation  Pharexcel Consulting 
Address  Pharexcel Consulting, 11, 10th Cross, AYR lay out, Shettyhalli Jalahalli West,Bangalore.

Bangalore
KARNATAKA
560015
India 
Phone    
Fax    
Email  info@pharexcelconsulting.com  
 
Details of Contact Person
Public Query
 
Name  Mr Sunil Gupta 
Designation  Managing Director 
Affiliation  Nutra Grace 
Address  NUTRA GRACE; B-11/7 & 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA. Hyderabad TELANGANA 500039

Hyderabad
TELANGANA
500039
India 
Phone    
Fax    
Email  sunil@nutragrace.com  
 
Source of Monetary or Material Support  
NUTRA GRACE; B-11/7 & 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA 
 
Primary Sponsor  
Name  NUTRA GRACE 
Address  B-11/7 & 11/8, IDA Uppal; Hyderabad- 500039, Telangana, INDIA 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Giriraja KV  Rajalakshmi Hospital & Research Center  Dept. of General medicine, Ground floor, Room Number 1, 21/1, Lakshmipura Main Road, Vidyaranyapura Post Bangalore-560097
Bangalore
KARNATAKA 
9448039952

drgirirajkv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K582||Mixed irritable bowel syndrome. Ayurveda Condition: GRAHANIDOSHAH, (2) ICD-10 Condition:K580||Irritable bowel syndrome with diarrhea. Ayurveda Condition: GRAHANIDOSHAH, (3) ICD-10 Condition:K581||Irritable bowel syndrome with constipation. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Neemint capsules (Each enteric coated capsule contains Neem Oil 350 mg and Peppermint Oil 150 mg)  Dose: 2 capsules to be taken on empty stomach each day. Frequency: Once daily Route of administration: Oral Duration: 28 days 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects in the age group of 18-65 yrs (Inclusive of both genders).
2. Subjects with 2 or more symptoms like indigestion ,abdominal pain or cramps, nausea ,vomiting, bloating, constipation, diarrhoea, changes in bowel habits, loss of appetite.
3. Subjects/legal representative, willing to give a voluntary written informed consent.
4. Subjects should not participate in any other clinical study during participation in the current study
 
 
ExclusionCriteria 
Details  1. Subjects with any cardiovascular, renal, respiratory or any other chronic illness.
2. Pregnant or lactating females.
3. Allergy to test product.
4. Any subject, in the investigators opinion not considered suitable for enrollment.
5. Subject participating in a similar clinical study, currently or during the previous 90 days 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in Gastrointestinal Symptom Rating Scale [GSRS- IBS]  Baseline, 1 week, 2 Weeks and 4 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
IBS- Quality of life questionnaire  Baseline, Day 7, Day 14 and Day 28 
Change in Subject’s Global Assessment of Symptoms  Day 1 to Day 28 
Monitoring of AE and SAE  Day 1 to Day 14 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2021 
Date of Study Completion (India) 26/04/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/06/2021 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 colitisCrohn’s disease, or colon cancerAnti 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.

 
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