A clinical study of jalakumbhi kshar and varun shigru kwath in patients of garbhashaya Arbud with special reference to uterine fibroid.
- Conditions
- Neoplasm of unspecified behavior of other genitourinary organs. Ayurveda Condition: ARBUDAH,
- Registration Number
- CTRI/2023/09/057451
- Lead Sponsor
- State Ayurvedic College and Hospital Lucknow
- Brief Summary
**The study is entitled to-** A comparative clinical study to evaluate the efficacy of Jalkumbhi kshar and Varun Shigru kwath in the management of Garbhashaya Arbuda w.s.r Uterine fibroid.
**Objective of study-** To compare the efficacy of Jalkumbhi kshar and Jalkumbhi kshar alongwith Varun Shigru kwath in the management of Garbhashaya Arbuda w.s.r to Uterine fibroid.
**Type of study-** Randomised comparative open clinical trail.
**Administration of trail therapy -** Minimum 40 patients having symptoms of Garbhashaya Arbuda will registered into groups.
**Group A-** Jalkumbhi kshar 250 mg orally twice a day ( after clearance of menses)
**Group B-** Jalkumbhi kshar 250 mg orally twice a day and Varun Shigru kwath approx 50 ml in 2 divided dose orally ( after clearance of menses)
**Duration of trail-** Trail will be conducted for maximum 3 months.
**Follow up -** Next menstrual cycle after completion of treatment. To assess the efficacy of trail drugs.
**Criteria of selection of patients -**
Pre assessment criteria - Patients from Prasuti tantra and Stri Roga OPD & IPD of State Ayurvedic College Lucknow will be screened out by the symptoms related to Uterine fibroid and USG reports.
**Diagnostic Criteria -** Diagnosis of each case will be made the help of detailed history in respect to disease, family history, previous similar episode, physical and systemic examination as well as the investigations.
**Subjective Criteria -** 1) Menstrual abnormalities ( Menorrhagia)
2) Dysmenorrhea
3) Pain and heaviness in lower abdomen
4) Backache
5) Frequent urination
6) Constipation
**Objective Criteria -** USG ( lower abdomen)
**Laboratory Examination -** CBC , ESR
CT , BT
RBS
LFT
KFT
Urine routine and microscopic
Thyroid Profile ( if needed)
USG.
**Examination** - Per Abdominal examination
Local examination of external genital
Per speculum examination
Per vaginal examination.
**Assessment criteria -** Total effect of therapy will be evaluated and grouped according to following criteria on the basis of assessment of sign and symptoms.
Complete remission ( cured) - 100% relief in the symptoms.
Marked improvement -75-100% relief in the symptoms.
Moderate improvement - 50-74% relief in the symptoms.
Mild improvement - 25-49% relief in the symptoms.
Unchanged - less than 25% of relief in symptoms. .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 40
- Patients of age group between 25-45 years.
- Patients having Uterine fibroid size equal or less than 5 cm as per USG reprort.
- Single or multiple Uterine fibroid up to 3.
- Patients willing to participate in the study with proper written consent.
- Patient below the age of 25 years and above the age of 45 years.
- Uterine fibroid with pregnancy.
- Lactating mother.
- Woman with Hb less than 8gm/dl.
- Patient with any coagulative diseases.
- Patient using iucd or taking ocp.
- Patient suffering from any other pelvic pathology.
- Patient suffering from any chronic illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement of sign and symptoms of uterine fibroid. 60 days
- Secondary Outcome Measures
Name Time Method 1.Improvement of sign & symptoms of uterine fibroid. 2. Reduced size of uterine fibroid.
Trial Locations
- Locations (1)
State Ayurvedic College and Hospital Lucknow
🇮🇳Lucknow, UTTAR PRADESH, India
State Ayurvedic College and Hospital Lucknow🇮🇳Lucknow, UTTAR PRADESH, IndiaDr Swati RaniPrincipal investigator7888375930swatisingh10992@gmail.com