A clinical study to see the effect of an Ayurvedic treatment in patients suffering from precancerous lesions of cervix and its anticancer effect in cancer cells.
- Conditions
- Mild cervical dysplasia. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,
- Registration Number
- CTRI/2023/02/049857
- Lead Sponsor
- ANILA M
- Brief Summary
Cancer of cervix is second leading cause of death due to cancer . 5 lakh new cases are
diagnosed each year . National cervical screening program aims at reducing the mortality and
morbidity due to cervical cancer. Women in the age group of 25-65yrs are recommended to
have screening through Pap smear every 3yrs . Precancerous lesions of cervix are called
cervical intraepithelial neoplasia CIN .Human papilloma virus is the main cause of cervical
dysplasia Human Papilloma Viral (HPV) infection is seen in about 80% of women at some
point of their life time. In the general population a 6.6% estimated to have cervical HPV
infection. Persistance of HPV infection leads to high risk of developing precancerous lesions
of cervix leading to Invasive Cervical Cancer (ICC)..Screening and prevention of
precancerous lesions can be life saving to many patients.This study is an attempt to explore
the potential of ayurvedic treatment in preventing the progress of the disease at precancerous
stage a randomized controlled trial ,with one interventional group compared to a control
group .Interventional group will have a yonivasthi with tankana kshara solution in distilled
water . This will be compared to controi group which will have yonipratisaranam with
tankana kshara as per the conventional protocol. As per the classical text book
Rasatharangini, Tankana ksharam has been indicated for mouth ulcers, yonivasthi in pidakadi
rujam.This study aims at finding the effectiveness of yonivasthi with tankana solution in
precancerous lesions of cervix .Outcome will be assessed with pap smear and colposcopy at 6
months and 1 year and it will compared with control group. Descriptive data will be
categorised and analysed using descriptive statistics and quantitative data will be summarised
with mean and standard error. Studies on mineral and herbomineral drugs have become a
need of the hour with fast depletion in herbal resourses. In Vitro cell line study will be done
to find out the anticancer effect of tankana kshara Anticancer effect of tankana kshara in
Cervical Cancer cells- HeLa will be studied. Standard protocol for invitro studies will be
followed. Mitochondrial Tetrazolium Testing (MTT) assay for cellviability assessment,
Lactate Dehydrogenase leakage (LDH) Assay for cell membrane integrity study, Cell cycle
analysis for phase arrest analysis, Annexin V FITC Flowcytometry for conformation of
apoptosis shall be done. Primary data will be collected from the laboratory. Outcome
variables, apoptosis, separate percentages of cells in early apoptosis, late apoptosis, and
necrosis, percentage of cells arrested in various phases of cell division will be measured.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 172
- Females in age group 30-65yrs having regular menstrual cycles or who have attained menopause, with pathological vaginal discharge attending OPD and IPD of Dept of Prasuthitantra streerog, Govt.
- ayurveda college Thiruvananthapuram will be screened primarily with colposcopy, pap smear .Those who are diagnosed with ASCUS/koilocytic atypia CIN I/LSIL will be included in the study.
- Cervical intraepithelial neoplasia 2 Cervical intraepithelial neoplasia 3 Carcinoma in situ.
- Carcinoma cervix Third degree prolapse Pregnant women Women with diagnosed severe systemic illness.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method changes in colposcopy and Pap smear will be assesed 0th day ,181st day (after 6 months), 366th day ( after 1yr)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Government Ayurveda college, Thiruvananthapuram
🇮🇳Thiruvananthapuram, KERALA, India
Government Ayurveda college, Thiruvananthapuram🇮🇳Thiruvananthapuram, KERALA, IndiaANILA MPrincipal investigator9048230814dranila.ayur@gmail.com