| CTRI Number |
CTRI/2025/04/085332 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study Efficacy of Karpas Moola Churna in Shwetapradar With Special Reference to Bacterial Vaginosis |
|
Scientific Title of Study
|
Randomized Controlled Trial on Efficacy of Karpas Moola Churna in Shwetapradar With Special Reference to Bacterial Vaginosis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snehal Pralhad Patil |
| Designation |
M.S Scholar Prasuti evam Stri Roga |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
| Address |
Opd no-2,Department of Prasuti evam Stri Roga,Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9552455935 |
| Fax |
|
| Email |
snehalpatil2228@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPradnya Shirke |
| Designation |
M.S Prasuti evam Stri Roga |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
| Address |
Opd no-2,Department of Prasuti evam Stri Roga,Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9623446110 |
| Fax |
|
| Email |
pradnyashirke2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Snehal Pralhad Patil |
| Designation |
M.S Scholar Prasuti evcam Stri Roga |
| Affiliation |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
| Address |
Opd no-2,Department of Prasuti evam Stri Roga,Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9552455935 |
| Fax |
|
| Email |
snehalpatil2228@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
|
|
Primary Sponsor
|
| Name |
Snehal Pralhad Patil |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
| 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 |
| Snehal Pralhad Patil |
Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune |
OPD no-2 and IPD,Department of Prasuti evam Stri Roga,Dr.D.Y.Patil College of Ayurveda and Research Centre,Pimpri,Pune
Pune
MAHARASHTRA |
9552455935
snehalpatil2228@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y.Patil College of Ayurveda and Research Centre,Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N898||Other specified noninflammatory disorders of vagina. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tablet Metronidazole, Reference: NA, Route: Oral, Dosage Form: , Dose: 400(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karpas Moola Churna, Reference: Vrindamadhav, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Tandulodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patient with Symptoms of Bacterial Vaginosis
Whitish or Yellowish-white or Grayish-white,milky,malodorous,thin,adherent vaginal discharge
Vaginal pH-more than 4.5
Wet Mount Test-Positive for Bacterial Vaginosis |
|
| ExclusionCriteria |
| Details |
Pregnant women
Genital Prolapsed
Pelvic Inflammatory disease
Other Vaginal Infections like vaginal Candidiasis,Chlamydia Bacterial Infection,Trichomonas Vaginalis |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the effect of karpas moola churna to change in value of vaginal PH in bacterial vaginosis |
Twice a day for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the effect of karpas moola churna to reduce the symptom of vaginal discharge in bacterial vaginosis |
Twice a day for 7 days |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
02/06/2025 |
| 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="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 is an open labelled randomized controlled clinical study.The aim of this study is to evaluate the efficacy of karpas moola churna in the management of shwetapradar with special reference to bacterial vaginosis.Total 44 participants will be enrolled in 2 groups(22 in each group).Group A(Trial group)will be treated with Karpas moola churna and Group B(Controlled group)will be treated with Tablet Metronidazole.Age group for an inclusion criteria will be 21-45 years female with the symptoms of bacterial vaginosis.The final conclusion will be drawn on the basis of statistical methods. |