| CTRI Number |
CTRI/2025/06/089825 [Registered on: 30/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the efficacy of application of apamarga alkali with triphala tablet and kushtadi vaginal suppository with triphala tablet orally in the management of cervical erosion
|
|
Scientific Title of Study
|
An open label double arm clinical study to compare the efficacy of apamarga pratisaraneeya kshara with triphala guggulu and kushtadi yoni varti with triphala guggulu orally in the management of garbhashaya greevamukha gata vrana
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Malini G |
| Designation |
PG Scholar |
| Affiliation |
skamch and rc |
| Address |
Room no. 209
Department of Prasooti Tantra evum Stree Roga
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
10 Pipeline Road, RPC Layout
Vijayanagar, Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
7019252924 |
| Fax |
|
| Email |
maliniganiger05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anupama |
| Designation |
HOD, Professor of prasooti tantra and stree roga |
| Affiliation |
skamchrc |
| Address |
Room no. 209
Department of Prasooti Tantra evum Stree Roga
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
10 Pipeline Road, RPC Layout
Vijayanagar, Bengaluru
Bangalore
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anupama |
| Designation |
HOD, Professor of prasooti tantra and stree roga |
| Affiliation |
skamchrc |
| Address |
Room no. 209
Department of Prasooti Tantra evum Stree Roga
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
10 Pipeline Road, RPC Layout
Vijayanagar, Bengaluru
KARNATAKA
560104
India |
| Phone |
9845442660 |
| Fax |
|
| Email |
dr.anupama.v@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Malini G |
| Address |
Room no. 209
Department of Prasooti Tantra evum Stree Roga
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
10 Pipeline Road, RPC Layout
Vijayanagar, Bengaluru |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
Not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr kiran m goud |
Department Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
Room no. 209
Department of Prasooti Tantra evum Stree Roga
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre
10 Pipeline Road, RPC Layout
Vijayanagar, Bengaluru
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N86||Erosion and ectropion of cervix uteri. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShAra-karma, कà¥à¤·à¤¾à¤°-करà¥à¤® | (Procedure Reference: Sushrutha samhita, Procedure details: The cervix will be exposed by introducing the cusco s speculum under all aseptic precautions
Kshara will be applied over the affected area with a cotton swab wrapped around a straight artery forceps
After kshara application observation for 100 matrakala will be done
If the vrana dagdha lakshanas are seen before 7 days the treatment will be stopped
Then pramarjana will be done with nimbuswarasa
)
(1) Medicine Name: Apamarga, Reference: Sushrutha samhita, Route: Vaginal, Dosage Form: Kshara, Dose: 1(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | yoni varti, योनि वर्ति | (Procedure Reference: Charaka samhita , Procedure details: Everyday Insertion of One Kushtadi Yoni Varti in to the Vagina for 3 hours or until the patient gets urge for micturition, whichever is earlier. Followed by yoni prakshalana with panchavalkala kwatha. )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients with diagnosed case of Garbhashaya Greevamukhagata Vrana
Married women between the age group of 20 to 50 years
|
|
| ExclusionCriteria |
| Details |
Pregnant women and puerperal women
Subjects on ocps and iucds
Subjects with systemic disorders which interfere with the course of treatment
Subjects of cervical carcinoma
Subjects with sexually transmitted diseases
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Extent of cervical erosion |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/09/2025 |
| 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="1"
Months="6"
Days="5" |
|
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
|
Garbhashaya greevamukha gata Vrana meaning gaathra vichurnane means that which disturbs the continuity of membranes and is manifested as yoni srava yoni kandu kati shoola and udara shoola and and there are few references for vrana of female genital tract ( yonigata vrana ) in ayurvedic classics Acharya Sushruta has mentioned Kshara Karma and varti kalpana under the shashti upakrama in Dvivraniya Chikitsa Adhyaya Kshara can be used effectively in treating cervical erosion as it is having Ushna Teekshna Chedana Bhedana Lekhana Sodhana Ropana properties Whereas Varti having Lekhana and Ropana properties are also used in treating cervical erosion And varti pramana is considered as explained in sharangadara uttara kanda |