| CTRI Number |
CTRI/2025/06/089384 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
23/06/2025 |
| 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 The Effect Of Palashadi Churna Orally And Guduchyadi Kadha Douche In Vaginal Discharge. |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial To Study The Effect Of Palashadi Churna Orally And Guduchyadi Kwatha Yonidhawan In Kaphaj Yonivyapad With Special Reference To Trichomonas 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 Nupura Dilip Lakhan |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department Of Prasuti Tantra And Strirog SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik Maharashtra
Nashik
MAHARASHTRA
422403
India |
| Phone |
8850453120 |
| Fax |
|
| Email |
nupuralakhan1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Sureshchandra Gholap |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department Of Prasuti Tantra And Strirog SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik Maharashtra
Nashik
MAHARASHTRA
422403
India |
| Phone |
9820304881 |
| Fax |
|
| Email |
drSameer.gholap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nupura Dilip Lakhan |
| Designation |
PG student |
| Affiliation |
Department Of Prasuti tantra evum Streeroga SMBT Ayurved hospital |
| Address |
Department Of Prasuti Tantra And Strirog SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik Maharashtra
Nashik
MAHARASHTRA
422403
India |
| Phone |
8850453120 |
| Fax |
|
| Email |
nupuralakhan1111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Prasuti Tantra And Strirog SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik Maharashtra India 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Nupura Dilip Lakhan |
| Address |
Department Of Prasuti Tantra And Strirog SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik Maharashtra |
| 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 Nupura Lakhan |
SMBT Ayurved College And Hospital |
OPD No.5 Department Of Prasutitantra evum Streeroga SMBT Ayurved College And Hospital Nandi Hills Dhamangaon Igatpuri Nashik
Nashik
MAHARASHTRA |
8850453120
nupuralakhan1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N760||Acute vaginitis. 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: Pippalyadi churna, Reference: Charak smahita chikitsa sthan adhyay no 30 shlok no 84, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Palashadi Churna , Reference: Ashtang sangraha uttar tantra adhyaya No 39 shlok no 53, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Female |
| Details |
Married Patients Having Symptoms Of Kaphaj Yonivyapada i.e. Vaginal Discharge Pruritis Vulvae Dull pain |
|
| ExclusionCriteria |
| Details |
Unmarried, Pregnant, Post-natal Women.
Infections Like Syphilis, HIV, Herpes Genitalia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction In Signs And Symptoms Of Kaphaj Yonivyapad After Taking Palashadi Churna Orally And Guduchyadi Kwath Yonidhwana. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| When The Trial Group Stands In Comparison With Control Group. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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 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
|
Kaphaj yonivyapad is a common gynaecological problem and it hampers day to day activity of woman and make them go through mental trauma of fear and guilt. The prevalence rate of Kaphaj yonivyapad (i.e. trichomoniasis) is 8.5%. Ayurvedic treatment for the management of Kaphaj yonivyapad could be safe, effective, readily available and with less side effect. For the management of Kaphaj yonivyapad both oral and local medication would have great impact.Since no work has been done on Palashadi Churna Orally in Kaphaj Yonivyapad With Special Reference To Trichomonas Vaginitis and no comparative has been conducted out. So it will help to fill knowledge gap.
Including the married female patient having sign and symptoms of Kaphaj Yonivyapad like P/V discharge, Itching and pain at vulval site between age group of 18-49 year who fulfill clinical diagnostic criteria. Written consent is taken from patient to ensure ethical compliance and transparency in research process. Sample size calculated is 35 in each group by using formula by Daniel 1999. Simple random sampling technique will be used. Total 70 number of patients will be divided in two group named as Group A (trial group and Group B (control group). Palashadi churna orally to group A (Trial group), Pippalyadi churna orally to group B (control group) will be given to patients. Guduchyadi Yonidhawan will be given to both groups. Drugs will be purchased from GMC certified pharmacy. Both drugs will be administered for 7 days. All SOP of Churna preparation and kawatha preparation and Yonidhawan procedure will be followed throughout the clinical trial. Observation will be done on 0th and 7th day of treatment. Follow will be taken on 14th day
Result will be drawn on basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observation and result obtained during treatment. Summary will be drawn out. |