A Clinical Trial to study the effect of the Drug Naaval nei in patients with high bleeding during menstruation
- Conditions
- Pitha Perumbadu (Menorrhagia)
- Registration Number
- CTRI/2017/05/008615
- Lead Sponsor
- Govt Siddha Medical College
- Brief Summary
This is a single arm open clinical trial to study the safety and efficacy of Siddha trial drug Naaval nei. The trial drug is given 5 ml twice a day for 48 days. Clinical trial is conducted after conducting Preclinical toxicity study. The trial drug Naaval nei is mentioned in aathmaratchamirtha Vaithiya Saara Sangiragam. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Female
- Target Recruitment
- 20
Patients with the following signs and symptoms Excessive menstruation Prolonged menstruation Presence of Blodd clots in menstrual bleeding Lower abdominal pain Low back ache Triedness during menstruation Giddiness during menstruation Head ache durring menstruation USG report with Fibroid uterus or PCOD or Ovarian cyst.
Pelvic pathology Diabetes mellitus Hypertension Patients having IUCD Abortion Thrombocytopenic purpura Coagulopathy Severe Anemia (<6 gm) Hypothyroidism Vulnerable population such as HIV and TB affected individuals.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome is mainly assessed by reduction in clinical symptoms and by comparing the following parameters before and after treatment. 48 days Reduced amount of blood flow is assessed by bleeding time, clotting time And Haemoglobin 48 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Arignar Anna Government Hospital of Indian Medicine
🇮🇳Chennai, TAMIL NADU, India
Arignar Anna Government Hospital of Indian Medicine🇮🇳Chennai, TAMIL NADU, IndiaDr S JayapriyaPrincipal investigator9894529964jpsubi2009@gmail.com