Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
None listed
Sponsors
Dr Vaidyas
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or Female Study Participants aged between 18 to 50 years inclusive at the first time of signing of the informed consent 2 Completed the screening process within 3 days prior to Randomization. 3 Study participant has understood and signed the informed consent form to participate in the study 4 Study participant willing to be available for the entire study period and to adhere to protocol requirements as evidenced by signing informed consent document 5 Study participant should be diagnosed with 1st 2nd degree internal or external piles
Exclusion criteria
Exclusion criteria: 1 Reports any presence or history of a clinically significant disorder involving the cardiovascular respiratory renal urologic hepatic immunologic endocrine or neurologic system or psychiatric diseases as determined by the investigator 2 Systolic blood pressure less than 100 mmHg or more than 140 mmHg 3 Diastolic blood pressure less than 60 mmHg or more than 90 mmHg. Minor deviations may be acceptable at the discretion of the investigator 4 Pulse rate below 60 beats per minute or above 100 beats per minute 5 Reports smoking of more than 5 cigarettes per day and use of more than 4 packets per day of tobacco products or use of nicotine products corresponding to more than 5 cigarettes per day or who are unable to abstain from smoking during the participation in the study 6 Reports a history of drug or alcohol addiction or abuse within the past 1 year Alcohol abuse defined as consumption of more than 21 units per week One unit of alcohol equals 500 mL of beer or 200 mL of wine or 50 mL of spirit 7 Reports history or presence of hepatitis B surface antigen and hepatitis C antibody or HIV antibody 8 Reports a clinically significant illness other than Hemorrhoids during the 30 days prior to randomization as determined by the investigator 9 Reports a history of allergic response to the active ingredient or related drugs 10 Reports a history of clinically significant allergies including food or drug allergies 11 Use of any prescription drug therapy or over the counter drugs 14 days prior to receiving the first dose of study medication or repeated use of drugs within last 14 days 12 Any other condition, that in the investigatorâ??s judgment might compromise patient safety or affect study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A.Size of Piles Mass from baseline to end to treatment Size of pile mass can be graded by- (Vas ) 1. Less than 0.5 cm 2. 0.5 to 1.0 cm 3. 1.1cm to 1.5 cm 4. 1.6 cm to 2.0cm 5. More than 2.0cm Period of straining : 1. Less than 5 minutes 2. 5.1 to 10minutes 3. 10.1 to 15minutes 4. 15.1 to 20minutes 5. More than 20 minutes Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| a. Changes in Laboratory Safety Parameters (CBC, LFT,KFT) from baseline to end of the study. (Only If reports are available) b. Change in Vital signs from baseline to end of therapy. c. Assessment of Adverse Events and the Serious Adverse Events in all the enrolled Study Participants Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr Varsha Tangade
Dr G D Pol Foundation YMT Ayurved College and Hospital
Outcome results
None listed