| CTRI Number |
CTRI/2023/07/055880 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to evaluate the effect of Udumbara Kashaya Yoni Prakshalana in Vaginitis |
|
Scientific Title of Study
|
A Randomized Open-Labelled Controlled Clinical Study To Evaluate The Efficacy Of Udumbara Kashaya Yoni Prakshalana In Shweta Pradara w.s.r To Vaginitis. |
| 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 Afreen Kousar Ali |
| Designation |
PG Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Sri Sri College Of Ayurvedic Science And Research Hospital Department Of Prasuti Tantra And Stree Roga OPD no 10, 21st Km Kanakapura Road Udayapura Post Bengaluru Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
7406152013 |
| Fax |
|
| Email |
affi.shiny@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Kagga |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Sri Sri College Of Ayurvedic Science And Research Hospital Department Of Prasuti Tantra And Stree Roga OPD no 10, 21st Km Kanakapura Road Udayapura Post Bengaluru Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
9739766448 |
| Fax |
|
| Email |
drcrajanii@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Kagga |
| Designation |
Associate Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Hospital |
| Address |
Sri Sri College Of Ayurvedic Science And Research Hospital Department Of Prasuti Tantra And Stree Roga OPD no 10, 21st Km Kanakapura Road Udayapura Post Bengaluru Karnataka
Bangalore
KARNATAKA
560082
India |
| Phone |
9739766448 |
| Fax |
|
| Email |
drcrajanii@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science And Research Hospital Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr AFREEN KOUSAR ALI |
| Address |
SRI SRI COLLEGE OF AYURVEDIC SCIENCE AND RESEARCH, HOSPITAL 21st KM KANAKAPURA ROAD UDAYAPURA POST BENGALURU - 560082
|
| Type of Sponsor |
Other [SELF] |
|
|
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 Afreen Kousar Ali |
Sri Sri College Of Ayurvedic Science And Research Hospital |
Sri Sri College Of Ayurvedic Science And Research Hospital Department Of Prasuti Tantra And Stree Roga OPD no 10, 21st Km Kanakapura Road Udayapura Post Bengaluru Karnataka
Bangalore
KARNATAKA |
7406152013
affi.shiny@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: SHWETA PRADARA, (2) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: TRIPHALA, Reference: YOGARATNAKARA , Route: Vaginal, Dosage Form: Kwatha/ Kashaya, Dose: 2000(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: UDUMBARA, Reference: KAIYADEVA NIGHANTU, Route: Vaginal, Dosage Form: Kwatha/ Kashaya, Dose: 2000(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Subjects between the age group of 20-40 years.
2. Subjects willing for Per speculum and Per vaginal examination.
3. Married woman.
4. Subjects presenting classical symptoms of Shwetha Pradara.
5. Subjects with the classical symptoms of Vaginitis.
6. Subjects willing to sign the consent form.
|
|
| ExclusionCriteria |
| Details |
1. Unmarried women.
2. Women below 20 years and above 40 years.
3. Pregnant woman.
4. Subject with known case of Benign and Malignant tumors.
5. Subject with known case of PID.
6. Subject with known case of Cervicitis.
7. Subject with known case of Systemic disorders.
8. Subject with known case of STDs (Syphilis, Chlamydia, Gonorrhea).
|
|
|
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 |
| Complete reduction in white discahrge |
Before treatment 0th day
After treatment 7th day
Follow up 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in itching, burning micturition, backache, foul smell in discharge |
Before treatment 0th day
After treatment 7th day
Follow up 15th day |
|
|
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 |
|
Date of First Enrollment (India)
|
10/08/2023 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [affi.shiny@gmail.com].
- For how long will this data be available start date provided 15-04-2025 and end date provided 17-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
• Shweta Pradara is a Kaphaja disorder in region of Apana Vayu, as a type of Srava which is resulted from Kapha Dosha. It is a symptom and disease itself of Stree Rogas that occur due to vitiation of Kapha. • It is characterized by subject showing classical symptom of Shweta Pradara with or without pruritus, foul smell, associated with problems like low back pain, lower abdomen pain, mental stress, sexual anxiety and local discomfort. •The white discharge may start as a simple problem and may lead to pelvic inflammatory diseases, menstrual irregularities, infertility and other obstetric complications like premature labor, PROM, intrauterine infection and perinatal complications. •The term Vaginitis is the diagnosis given to women who complain of abnormal vaginal discharge with vulvar burning, irritation, or itching. It is one of the most frequent reasons for patient visits to the gynecologist. •Yoni Prakshalana is a cleansing procedure which helps in removing the excessive and abnormal vaginal discharges along with harmful microorganisms, by promoting new tissue growth, thus heals unhealthy vaginal mucosa, reduces the inflammation and congestion in order to maintain the normal vaginal flora. • Yoni Prakshalana with Udumbara Kashaya is expecting to give beneficial results in Shweta Pradara and hence it is taken up for this study.
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