A Randomized Controlled Clinical Trial to Evaluate the Effect of Lajjalu Siddha Taila Yonipichu in the Management of Garbhashaya Mukhagat Vrana with Special Reference to Cervical Erosion.
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 70
- Locations
- 1
Study Overview
Brief Summary
Cervical erosion is common beningn condition of cervix in women of reproductive age and is associated with symptoms such as vaginal discharge,itching,dyspareunia and low backache.Conventional treatmenta like cauterization ,cryotherapy though effective,may be invasive,uncomfortable,and associated with recurrence or limited accessibility.In ayurveda ,cervical erosion can be correlated with Garbhashaya mukhgata vran .Yonipichu is locally acting therapy providing sustained drug contact and promoting mucosal healing . Lajjalu(Mimmosa pudica Linn.) possesses vranaropana , stambhana ,shothhar properties and has shown wound healing potential.
This randomized controlled clinical trail aims to evaluate the effficacy and safety of lajjalu siddha tail yonipichu compared to jatyadi tail yonipichu in patients with cervical erosion . Seventy participients will br randomized in two groups and treated for seven days in post menstrual phase .Outcomes will be assessed based on subjective symptoms and objective cervical findings to establish a safe ,cost effective and non invasive management option.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 19.00 Year(s) to 50.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1 Women aged 19 to 50 years will be included in the study.
- •2 Married women will be selected irrespective of parity.
- •3 Presence of cervical erosion will be confirmed on per speculum examination.
- •4 Women presenting with signs and symptoms such as vaginal discharge, post-coital bleeding, low backache, and dyspareunia will be included.
Exclusion Criteria
- •1 Women who are pregnant or in the postpartum period within 6 weeks will be excluded.
- •2 Patients currently using oral contraceptive pills will be excluded.
- •3 Known cases of cervical intraepithelial neoplasia or previously treated cervical carcinoma will be excluded.
- •4 Patients showing malignant changes on Pap smear examination will be excluded.
- •5 Patients who are HIV, HBsAg, or VDRL positive will be excluded.
- •6 Women with intrauterine contraceptive device insertion will be excluded.
- •7 Patients suffering from severe systemic disorders such as uncontrolled diabetes mellitus, tuberculosis, or hypertension will be excluded.
Investigators
Vd Sheela Sambhaji Chavan
R A Podar Medical College (Ayu),Worli,Mumbai,400018.