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CTRI Number  CTRI/2023/02/049857 [Registered on: 20/02/2023] Trial Registered Prospectively
Last Modified On: 15/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   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. 
Scientific Title of Study   Effectiveness of modified Ayurvedic treatment in Precancerous lesions of cervix and anticancer effect in cervical cancer HeLa Cell line. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANILA M 
Designation  Assistant Professor  
Affiliation  Govt Ayurveda College Thiruvananthapuram 
Address  Department of Prasuthithantra Strirog, Govt. Ayurveda College, Thiruvananthapuram KERALA 695001 India
sruthi,sreenagar,venchavode,sreekariyam,Thiruvananthapuram KERALA 695017 India
Thiruvananthapuram
KERALA
695001
India 
Phone  9048230814  
Fax    
Email  dranila.ayur@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Asha Sreedhar 
Designation  Professor,HOD Department of Prasutitantra and Streeroga  
Affiliation  Govt Ayurveda College Thiruvananthapuram 
Address  Department of Prasuthithantra Strirog, Govt. Ayurveda College, Thiruvananthapuram Govt. Ayurveda College Thiruvananthapuram, kerala, Thiruvananthapuram KERALA 695001 India
Thiruvananthapuram KERALA 695001 India
Thiruvananthapuram
KERALA
695001
India 
Phone  9048230814  
Fax    
Email  drashaajith@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr AnilaM 
Designation  Assistant Professor  
Affiliation  Govt Ayurveda College ,Thiruvananthapuram 
Address  Dept of Prasuthithantra Streeroga ,Govt Ayurveda college Thiruvananthapuram

Thiruvananthapuram
KERALA
695001
India 
Phone  9048230814  
Fax    
Email  dranila.ayur@gmail.com  
 
Source of Monetary or Material Support  
Govt Ayurveda College ,Thiruvananthapuram,Kerala 695001,INDIA 
 
Primary Sponsor  
Name  ANILA M 
Address  Assistant professor Dept of Prasuthithantra Strirog Govt Ayurveda College Thiruvananthapuram 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
ANILA M  Government Ayurveda college, Thiruvananthapuram  Department of prasutitantra and streeroga Govt Ayurveda College,Thiruvanathapuram
Thiruvananthapuram
KERALA 		 9048230814

dranila.ayur@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N870||Mild cervical dysplasia. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-yoni picu, योनि पिचु (Procedure Reference: rasatarangini, Procedure details: The mucous over the cervix will be cleaned properly with cotton swab soaked in sterile water by a sponge holding forceps Tankana kshara will be applied on the part of lesion with a cotton piece ,after covering the surrounding parts with cotton pieces,it will be held in place for 3 minutes ,washed away with distilled water ,process repeated 2 times at an interval of 7 days ,repeated in 2 more cycles)
(1) Medicine Name: tankana kshara, Reference: rasatarangini, Route: Vaginal, Dosage Form: Kshara, Dose: 2(g), Frequency: od, Duration: 9 Days
2Intervention ArmProcedure-yoni pUraNa , योनि पूरण  (Procedure Reference: rasatarangini, Procedure details: The mucous over the cervix will be cleaned properly with cotton swab soaked in sterile water by a sponge holding forceps with a sterile syringe tankana kshara solution was administered in a constant stream and retained for 3 minutes .This procedure was repeated for 7 consecutive days,repeated in 2 more cycles)
(1) Medicine Name: tankana kshara solution, Reference: rasatarangini, Route: Vaginal, Dosage Form: Kshara, Dose: 2.5(g), Frequency: od, Duration: 21 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  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 
 
ExclusionCriteria 
Details  Cervical intraepithelial neoplasia 2
Cervical intraepithelial neoplasia 3
Carcinoma in situ.
Carcinoma cervix
Third degree prolapse
Pregnant women
Women with diagnosed severe systemic illness 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
changes in colposcopy and Pap smear will be assesed
 		 0th day ,181st day (after 6 months), 366th day ( after 1yr) 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="172"
Sample Size from India="172" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   23/02/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.
 
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