| CTRI Number |
CTRI/2025/07/090172 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Kshara karma(Parasurgical procedure), Yoni pichu(vaginal tampon)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Application of mild Indian Laburnum Alkali and medicated Indian Laburnum oil tampon for the treatment of Swelling, ulcer and discharge on cervix. |
|
Scientific Title of Study
|
A Randomized Open Labelled Controlled Clinical Study To Evaluate The Efficacy Of Aragvadha Pratisaraneeya Mridu Kshara And Aragvadha Taila Pichu In The Management Of karnini Yonivyapat With Special Reference To 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 Padhma Sree M |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga, Room No.10,Sri Sri College Of Ayurvedic Science and Research Hospital,Kanakapura Road,Udayapura P.O. Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
8078151804 |
| Fax |
|
| Email |
padhmasreemuraleedharan697@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Kagga |
| Designation |
Associate Proffessor |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga, Room No.10,Sri Sri College Of Ayurvedic Science and Research Hospital,Kanakapura Road,Udayapura P.O. Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9739766448 |
| Fax |
|
| Email |
drcrajanii@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Kagga |
| Designation |
Associate Proffessor |
| Affiliation |
Sri Sri College Of Ayurvedic Science and Research |
| Address |
Department Of Prasuti Tantra And Stree Roga, Room No.10,Sri Sri College Of Ayurvedic Science and Research Hospital,Kanakapura Road,Udayapura P.O. Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
9739766448 |
| Fax |
|
| Email |
drcrajanii@gmail.com |
|
|
Source of Monetary or Material Support
|
| sri sri college of ayurvedic sceince and research hospital, bengaluru, karnataka state,India 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Padhma Sree M |
| Address |
Sri Sri College Of Ayurvedic Science and Research ,Kanakapura road, Udayapura P.O. 5600082 |
| Type of Sponsor |
Other [Dr Padhma Sree M] |
|
|
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 Padhma Sree M |
Sri Sri College of Ayurvedic Science and Research |
Department Of Prasuti Tantra And Stree Roga, Room No.10,Sri Sri College Of Ayurvedic Science and Research Hospital,Kanakapura Road,Udayapura P.O. Bangalore-560082
Bangalore
KARNATAKA |
8078151804
padhmasreemuraleedharan697@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Commitee |
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: KARNINI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | kShArakarma, क्षारकर्म Pradhan Karma | (Procedure Reference: SUSRUTHA SAMHITHA, Procedure details: ONE SITTING)
(1) Medicine Name: ARAGVADHA MRIDU PRATISARANEEYA KSHARA, Reference: SUSRUTHA SAMHITHA, Route: Vaginal, Dosage Form: Kshara, Dose: 1(mg), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm | Procedure | - | kShArakarma, क्षारकर्म | (Procedure Reference: susrutha samhitha, Procedure details: one sitting)
(1) Medicine Name: tankana, Reference: susrutha, Route: Vaginal, Dosage Form: Kshara, Dose: 1(mg), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Subjects aged between 20 to 50 years and married.
2.Subjects with Cervical Erosion on Per Speculum examination.
3.Patients suffering from classical symptoms of Karnini Yoni Vyapat like Karnika, Yonigata Srava, and Yoni Kandu.
4.Patients suffering from classical symptoms of Cervical Erosion like vaginal discharge, post coital bleeding, dyspareunia, features of cervicitis like pelvic pain, backache, burning micturition.
5.Subjects who are fit for Kshara karma.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who are unmarried, pregnant and lactating.
2.Subject who had undergone Cryosurgery, Thermal cauterization, Loop electrosurgical excision procedure (LEEP).
3.Subjects on Intra Uterine Contraceptive Device (IUCD), Hormonal Pills, Alcohol, smoking, Drug abuse.
4.Subjects with Acute Pelvic Inflammatory Disease (PID).
5.Subject with Known case of Pre-malignant and Malignant lesions of Cervix and other organs.
6.Subjects with known case of Congenital Anomalies, Psychiatric Disorders, severe Systemic Illness, STDs and HIV.
7.Subjects who are Kshara Karma Anarha.
8.Subjects who are not willing to sign the consent form.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Significant decrease in Cervical Erosion and its signs and symptoms based on subjective and objective parameters.
|
Significant decrease in Cervical Erosion and its signs and symptoms based on subjective and objective parameters with in 7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in - depth analysed data on the different aspect of the disease.
Generation of data on possible unexpected drug reaction.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
14/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Kshara
Karma having
the properties of Shodhana, Lekhana, Ropana, Stambhana, Kaphaghna ,
Apunarbhava will
act on muscular sprouts and can help in managing karnini yonivyapat(Cervical Erosion) . Aragvadha,
is one among the Shodhana Gana mentioned
by Acharya Sushruta, having Doshakarma
as Kaphapittanashaka, Vrana Shodhana, Kandugna, Kushtagna, Krimihara properties when applied in the form of kshara and taila pichu can help in managing karnini yonivyapat(Cervical Erosion). |