Role of individualized homoeopathic medicine in the treatment of adenomyosis: An open label prospective clinical trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Numeric Rating Scale (NRS) Measurement for menstrual pain. The NRS is one of
Study Overview
Brief Summary
i. A minimum of 30 samples will be taken in this study.
ii. Inclusion & exclusion criteria will be strictly maintained.
iii. Cases will be taken in standard case taking format.
iv. Data from the patients will be taken in details according to the instructions given in Organon of Medicine.
v. Data/score will be recorded at baseline and on NRS at baseline and after 3 months and 6 months.
vi. Menstrual blood loss will be assessed on PBAC at baseline, 3rd month and 6th month.
vii. Each case will be studied properly through evaluation of symptoms & construction of qualitative totality of symptoms.
viii. Each case will be assessed periodically or as per the need of the case to follow up the medicinal action through clinical assessment, expert opinion as well as relevant laboratory investigations.
ix. Statistical analysis will be done by comparing the data obtained at baseline and 6th month.
x. At the end of the study the result will be analysed with proper statistical technique to show whether the changes made by Individualized Homoeopathic medicine are significant or not.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Female patient with a positive diagnostic finding for adenomyosis.
- •Women of age group 18-60 years.
- •Patients willing to give consent for participating in the study.
- •Patients who can read Bengali and/or Hindi and/or English.
Exclusion Criteria
- •Pregnant women or lactating mothers.
- •Diagnosed cases of unstable psychiatric illness or other systemic disease affecting quality of life or some life-threatening illness.
- •Patients not willing to participate in the study.
- •Substance abuse and/or dependence.
Outcomes
Primary Outcomes
Numeric Rating Scale (NRS) Measurement for menstrual pain. The NRS is one of
Time Frame: At baseline and 6 month
the most commonly used scales having a range from 0-10, where ‘0’ denotes no pain
Time Frame: At baseline and 6 month
and ‘10’ denotes worst possible pain imaginable.
Time Frame: At baseline and 6 month
• Pictorial blood loss assessment chart (PBAC) measurement for menstrual
Time Frame: At baseline and 6 month
bleeding. The chart consists of a series of diagrams which depict staining, clots and
Time Frame: At baseline and 6 month
flooding. The number of sanitary pad/tampons used each day during menstruation is
Time Frame: At baseline and 6 month
recorded by placing a tally mark in the next box. For scoring row total is multiplied by multiplying factor for each row.
Time Frame: At baseline and 6 month
Secondary Outcomes
- n attempt will be made to show changes in the pathology through lab investigations – USG (lower abdomen and pelvis)/ TVS/MRI (lower abdomen and pelvis)(At baseline and 6 month)
Investigators
Arup Kumar Mondal
National Institute of Homoeopathy