A clinical study to study the effect of drug NELLI KUDINEER in RATHAMOOLAM(Bleeding Haemorrhoids)

Phase 2

Not yet recruiting

• Conditions: RATHAMOOLAM

• Registration Number: CTRI/2018/03/012713
• Lead Sponsor: Dr S Neelavathi Md PhD

Brief Summary

The study is A Prospective Open Labelled Phase II Non Randomized clinical study to evaluate the therapeutic efficacy of NELLI KUDINEER  100ml OD for 30 days  in 40 patients during the trial period of 15 months that will be conducted in Govt Siddha Medical College and hospital Palayamkottai Tirunelveli Tamilnadu The primary outcome will be the therapeutic efficacy of trial drug NELLI KUDINEER in RATHAMOOLAM  The secondary outcome will be the evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-02-23
• Study Start: 2018-03-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patient with haemorrhoids in grade I II III with clinical symptoms such as Bleeding per rectum Irregular bowel habits Constipation Prolapse of pile mass Itching around anus Tenesmus and Anemia.

Exclusion Criteria

Fissure Fistula in ano Prolapse of rectum Sentinel haemorrhoids Malignancy Rectal polyp Pregnant women Chronic Kidney,Liver and cardiac diseases.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Therapeutic efficacy of trial drug Nelli kudineer in Rathamoolam	30 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of Siddha diagnostic parameters Safety of trial drug Pharmacological and Biochemical analysis of trial drug	30 days

Trial Locations

Locations (1)

Govt Siddha Medical College and hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Govt Siddha Medical College and hospital

🇮🇳Tirunelveli, TAMIL NADU, India

Sumayya M

Principal investigator

9746242799

sumisuhyle@gmail.com