| CTRI Number |
CTRI/2025/05/086437 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
03/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the efficacy of Lodhradi Yonivarti in Shwetapradara |
|
Scientific Title of Study
|
An Open Randomised Controlled clinical trial to evaluate the efficacy of Lodhradi Yonivarti in the management of Shwetapradara |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Madhura Balu Kale |
| Designation |
PG Scholar |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
3rd floor Department of Prasutitantra evum Streerog APMs Ayurved Mahavidyalaya near Sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8329625709 |
| Fax |
|
| Email |
madhukale7276@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhura Balu Kale |
| Designation |
PG Scholar |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
3rd floor Department of Prasutitantra evum Streerog APMs Ayurved Mahavidyalaya near Sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA
400022
India |
| Phone |
8329625709 |
| Fax |
|
| Email |
madhukale7276@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Shrikant Jagtap |
| Designation |
HOD and Professor |
| Affiliation |
APMs Ayurved Mahavidyalaya Sion |
| Address |
Department of Prasutitantra evum Streeroga 3rd floor APMs Ayurved Mahavidyalaya near Sion railway station Sion East Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9820556568 |
| Fax |
|
| Email |
sujatashrikantjagtap@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Madhura Balu Kale |
| Address |
3rd floor Department of Prasutitantra evum Streerog APMs Ayurved Mahavidyalaya near Sion railway station Sion East Mumbai 400022 |
| 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 Madhura Balu Kale |
Seth RV Ayurvedic Hospital |
OPD No 8 Department of Prasutitantra evum Streerog APMs Ayurved Mahavidyalaya and Seth RV Ayurvedic Hospital near Sion railway station Sion East Mumbai 400022
Mumbai
MAHARASHTRA |
8329625709
madhukale7276@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sion Ayurved College IEC |
Approved |
|
|
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: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lodhradi yonivarti, Reference: Ashtang Sangrah Uttar sthan 39/73, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Clingen Forte (Vaginal Suppository) | Vaginal Route
Dose 1 Suppository
Frequency Hs
Duration 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Married patients of age 18 to 45 years.
2) Patients having p/v white discharge (srava) with sthanik kandu ,srava gandha ,katishool or any one
of these .
3) Patients ready to participate in study with proper written consent.
4) Patient irrespective of a) Religion
b) Cast
c) Socio economic status
d) Occupation |
|
| ExclusionCriteria |
| Details |
1) Pregnancy.
2) Patients with surgical intervention such as a Cervical polyp, uterine prolapse.
3) Patients suffering from HIV, STD, Hepatitis B.
4) Patients diagnosed with malignancies of genital tract.
5) Oral contraceptive pills users.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Srava pramana that is amount of discharge |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Srava gandha that is smell
sthanik kandu that is per vaginal itching
katishool that is backpain |
7 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
14/05/2025 |
| 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="2" |
|
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
|
Yonivarti is meant for Shodhana Karma.It is beneficial for treating conditions related
to vaginal canal and uterus. It helps cleanse the vaginal canal by removing harmful doshas and
supports the restoration of balanced vaginal health.The high vascularity of vaginal wall and pelvic
tissue enables faster absoption of drugs than oral administration.The anatomical position of vagina
also enhances the drug action in situ.Trial drug Lodhradi Yonivarti acts by its stambhaka,
sravanashaka, tridoshashamaka, vranaropana and kapha shodhana properties.
[8]
In Modern medicine,various formulations are used for vulvovaginal
infection.Control drug ‘Clingen forte’ contains fixed combination of Clindamycin, Clotrimazole
&Tinidzole ensures wide range of antimicrobial action with rapid and symptomatic relief in patient
infected by bacterial,fungal and protozoal origin. It gives significant relief from vaginal infection of
mixed origin.
[9]
Considering these properties of ‘Lodhradi Yonivarti’ and ‘Clingen forte (Vaginal suppository)’,
these drugs are selected for study. |