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CTRI Number  CTRI/2026/02/102724 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 31/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two Ayurvedic herbal powder application along with oral pill in cervical erosion. 
Scientific Title of Study   A Comparative Open-Label, Double-Arm, Clinical trial to study the combined efficacy of Arka Kshara with Nimbadi Guggulu and Apamarga Kshara with Nimbadi Guggulu in the management of Karnini Yoni Vyapad (Cervical Erosion) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sneha Shetkar 
Designation  PG Scholar  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Stri Roga Evam Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  7337645545  
Fax    
Email  snehashetkar24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prathima  
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Stree Roga Evam Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9611990497  
Fax    
Email  drprathima.jain@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sneha Shetkar 
Designation  PG Scholar  
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  
Address  Department of Stri Roga Evum Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India


KARNATAKA
573201
India 
Phone  7337645545  
Fax    
Email  snehashetkar24@gmail.com  
 
Source of Monetary or Material Support  
SDM College of Ayurveda and Hospital, Thanniruhalla, Hassan 573201  
 
Primary Sponsor  
Name  SDM College of Ayurveda and Hospital  
Address  Thanniruhalla, Hassan 573201 
Type of Sponsor  Private medical college 
 
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 
Dr Sneha Shetkar  SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA & HOSPITAL   OPD and IPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, Hassan 573201 Hassan KARNATAKA
Hassan
KARNATAKA 
07337645545

snehashetkar24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
nstitution Of Ethics Committee Sri Dharmasthala Manjunatheshwara College Of Ayurveda And Hospital Hassan   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. Ayurveda Condition: KARNINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: Sushruta Sutrasthanam 11/7, Procedure details: The participant will be instructed to void the bladder before being placed in the lithotomy position. Initial clinical assessment will be conducted via a per-vaginal examination, followed by local cleansing (Yoni Prakshalana) using lukewarm water (Ushna Jala). Under aseptic precautions, the cervix will be visualized using a Cusco’s speculum. The targeted lesion or affected area will be gently debrided with sterile gauze to remove mucus. Following preparation, the intervention involves the topical application of Apamarga Kshara using a sterile cotton swab. The application will continue until the desired medicinal endpoint is achieved, characterized by a dusky purple/blackish discoloration (Pakwa Jambu Phala Varna). To prevent chemical over-exposure, the alkaline action of the Kshara will be immediately neutralized using freshly prepared lemon juice (Nimbu Swarasa). Finally, the surrounding vaginal mucosa will be inspected for accidental chemical irritation, and the treated site will be protected with a sterile medicated gauze tampon (Pichu).)
(1) Medicine Name: Apamarga Kshara, Reference: Sushruta Sutrasthanam 11, Route: Vaginal, Dosage Form: Kshara, Dose: 5(mg), Frequency: od, Duration: 1 Days
2Comparator ArmProcedure-kShArakarma, क्षारकर्म (Procedure Reference: sushrut sutrasthana 11/7, Procedure details: The participant will be instructed to void the bladder before being placed in the lithotomy position. Initial clinical assessment will be conducted via a per-vaginal examination, followed by local cleansing (Yoni Prakshalana) using lukewarm water (Ushna Jala). Under aseptic precautions, the cervix will be visualized using a Cusco’s speculum. The targeted lesion or affected area will be gently debrided with sterile gauze to remove mucus. Following preparation, the intervention involves the topical application of Arka Kshara using a sterile cotton swab. The application will continue until the desired medicinal endpoint is achieved, characterized by a dusky purple/blackish discoloration (Pakwa Jambu Phala Varna). To prevent chemical over-exposure, the alkaline action of the Kshara will be immediately neutralized using freshly prepared lemon juice (Nimbu Swarasa). Finally, the surrounding vaginal mucosa will be inspected for accidental chemical irritation, and the treated site will be protected with a sterile medicated gauze tampon (Pichu).)
(1) Medicine Name: arka ksahara, Reference: sushrut sutrasthana 11/11, Route: Vaginal, Dosage Form: Kshara, Dose: 5(g), Frequency: od, Duration: 1 Days
3Intervention ArmDrugClassical(1) Medicine Name: nimbadi guggulu, Reference: Bharat Bhaishajya Ratnakar. Vol. III. 3rd ed., Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: ushnajala), Additional Information: -
4Comparator ArmDrugClassical(1) Medicine Name: nimbadi guggulu, Reference: Bharat Bhaishajya Ratnakar. Vol. III. 3rd ed., Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: ushnajala), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1 Sexually active women and clinically diagnosed and confirmed subjects of cervical erosion of 21-45 years of age and fulfilling the diagnostic criteria.
2 Participants who are ready to participate and have signed for informed consent form
 
 
ExclusionCriteria 
Details  1 Known case of cervical carcinoma, uterine prolapse
2 Known case of coagulation disorders
3 Participants with HIV, VDRL, HBsAg positive
4 Participants on oral contraceptive pills, those using Intra uterine Contraceptive devices
5 Participants with diagnosed case of CIN (Cervical intraepithelial neoplasia)

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Complete healing of cervical erosion on speculum examination.
 
15 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in vaginal discharge
 
30 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2 
Date of First Enrollment (India)   01/04/2026 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is designed as a comparative clinical trial to evaluate the efficacy of Arka Kshara against the established standard, Apamarga Kshara, in the management of Karnini Yoni Vyapad, which correlates clinically with Cervical Erosion (Cervical Ectopy). The research focuses on the therapeutic potential of Kshara Karma—utilizing the Dahana, Pachana, and Lekhana properties of these alkaline preparations—to facilitate the removal of abnormal columnar epithelium and promote the regeneration of healthy squamous epithelial layers. While Apamarga Kshara serves as the traditional gold standard, this study seeks to validate Arka Kshara (derived from Calotropis gigantea) as a novel alternative that may offer superior anti-inflammatory and wound-healing benefits with minimal local tissue damage.

To ensure standardized internal support and systemic detoxification, both treatment groups will receive Nimbadi Guggulu as an adjuvant. This combination is intended to provide Krimighna (antimicrobial) and Shothahara (anti-inflammatory) effects, thereby reducing the risk of infection and enhancing the Ropana (healing) process. Clinical outcomes will be measured by the reduction of symptoms such as excessive vaginal discharge, post-coital bleeding, and backache, alongside the visual observation of cervical tissue repair. Ultimately, the study aims to establish a safe, effective, and minimally invasive Ayurvedic protocol for women of reproductive age suffering from this common gynecological condition.

 
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