CTRI Number |
CTRI/2025/03/083397 [Registered on: 25/03/2025] Trial Registered Prospectively |
Last Modified On: |
19/03/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
A Study On The Effectiveness Of Pippalyadi Churna In Treating Yeast Infection. |
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Pippalyadi Churna In The Management Of Kaphaja Yonivyapad W.S.R To Vulvovaginal Candidiasis |
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 Prerna |
Designation |
PG Scholar |
Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh |
Address |
Department of Prasuti Tanta- Stree Roga Kunwar Shekhar Vijendra Ayurved
Medical College and Research Center Gangoh
Saharanpur UTTAR PRADESH 247341 India |
Phone |
7082152836 |
Fax |
|
Email |
prernasaini0001@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr R Jayalekshmi |
Designation |
Proffessor |
Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh |
Address |
Department of Prasuti Tanta- Stree Roga Kunwar Shekhar Vijendra Ayurved
Medical College and Research Center Gangoh
Saharanpur UTTAR PRADESH 247341 India |
Phone |
8838460272 |
Fax |
|
Email |
dr.lekshmy83@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr R Jayalekshmi |
Designation |
Proffessor |
Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh |
Address |
Department of Prasuti Tanta- Stree Roga Kunwar Shekhar Vijendra Ayurved
Medical College and Research Center Gangoh
Saharanpur UTTAR PRADESH 247341 India |
Phone |
8838460272 |
Fax |
|
Email |
dr.lekshmy83@gmail.com |
|
Source of Monetary or Material Support
|
Dr Prerna |
Kunwar Shekhar Vijendra Ayurved Medical College And Research Center Gangoh Saharanpur Uttar Pradesh 247341 |
|
Primary Sponsor
|
Name |
Dr Prerna |
Address |
Department of Prasuti Tanta- Stree Roga Kunwar Shekhar Vijendra Ayurved
Medical College and Research Center Gangoh Saharanpur Uttar Pradesh 247341
|
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 Prerna |
Kunwar Shekhar Vijendra Ayurved Medical Hospital And Research Center Gangoh Saharanpur-247341 |
Room number 2
Department Of Prasuti Tantra- Stree Roga
Kunwar
Shekhar Vijendra
Ayurved Hospital and Research
Center Gangoh Saharanpur Uttar Pradesh
Saharanpur UTTAR PRADESH |
7082152836
prernasaini0001@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center Gangoh Saharanpur |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Churna, Reference: ch. chi. 30/84, Route: Oral, Dosage Form: Churna/ Powder, Dose: 4.125(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
40.00 Year(s) |
Gender |
Female |
Details |
1.Enrolled patients with consent form.
2.Patient complaining of any two from
Yoni Srava (Vaginal Discharge)
Yoni Pichhilta(Vaginal Sliminess)
yoni Kandu (Itching)
Alpa Vedana (Mild Pain)
•Yoni Shitalta (Vaginal Coldness)
3.Microscopically positive for Pseudohyphae.
4.Women suffering from recurrent VVC
|
|
ExclusionCriteria |
Details |
1.Patients not willing to participate in the trial.
2.Unmarried women
3.Age less than18 or more than 40 years
4.Pregnant females and lactating mothers.
5.known cases of HTN, DM, Hypo and hyperthyroidism, TB.
6.Diagnosed patients of HIV, VDRL, HBsAg
7.Women with PID and cervical intraepithelial neoplastic lesions.
8.Women taking oral contraceptive pills.
|
|
Method of Generating Random Sequence
|
|
Method of Concealment
|
|
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Improvement in signs and symptoms of kapahaja yonivyapad |
1st,10th,20th, 30th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Improvement in quality of life
2.Prevention of recurrence |
10th,20th,30th 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/ Phase 3 |
Date of First Enrollment (India)
|
05/04/2025 |
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
|
Ayurvedic texts outline 20 specific
gynecological disorders, each with its own unique characteristics and
implications. Kaphaja Yonivyapad is one among most frequently seen conditions
out of these. It presents in the form of Pichhila
(sliminess), Sheeta (cold), Pandu varna (white colored) and Kandu
yukta srava (discharge with itching), Alpa Vedana (mild pain) of yoni. The sign and symptoms of Kaphaja Yoni Vyapad are correlated with
Candidiasis because the the description and characteristic features of the
disease have coincided with the description of Candidiasis more than any other
type of Yoniroga. Vulvovaginal Candidiasis is the infection of the
genital region which causes irritation, burning sensation, discharge (similar
to white cottage cheese) and intense itching of the vagina and the vulva — the
tissues at the vaginal opening. Yoni
being a direct route to Garbhashaya (uterus), if diseased can affect
entire Kshetra needed for growing embryo and its development. Hence it is
important to address this problem so that women can live a healthy life.
Present study is undertaken with a purpose to identify the effect of Pippalyadi
Churna in the management of Kaphaja Yonivyapad w.s.r. to Vulvovaginal
Candidiasis. Acharya Charaka mentioned use of this drug in yonisrava under
Kaphaja Yonivyapad Chikitsa in chapter 30 of chikitsa sthan.
At first, all participants will be
screened to check their eligibility for the study. A total of 30 clinically
diagnosed patients will be enrolled in this study after taking informed written
consent. After that, the first assessment will be done before drug
administration with a validated questionnaire and grading will be done
according to the signs and symptoms of the patients. Then the drug therapy will
be started and the total duration will be 30 days. Three follow ups will be
done each after 10 days. The last assessment will be done on the 30th day and
the grading will be given again to see the changes in the signs and symptoms of
kaphaja yonivyapad. Signatures on informed consent and patient information
sheets will be taken on hard copy, and all other relevant data for the study
will be collected. After the collection of all the relevant data, the analysis
of the data will be done. |