| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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 | | 3 | Intervention Arm | Drug | Classical | | (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: - | | 4 | Comparator Arm | Drug | Classical | | (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. |