FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/10/059311 [Registered on: 30/10/2023] Trial Registered Prospectively
Last Modified On: 19/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect Of Dantyadi Kashaya Yoni Prakshalana in Shweta Pradara with special reference to Candida vaginitis 
Scientific Title of Study   A Controlled Comparative Clinical Trial To Evaluate The Effect Of Dantyadi Kashaya Yoni Prakshalana In Shweta Pradara w.s.r. to Candida Vaginitis  
Trial Acronym  NIL 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nikita M Magennavar 
Designation  PG Scholar 
Affiliation  SDM Trusts Ayurvedic medical college Danigond Post graduation centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Dr Siddhant Nagar Terdal

Bagalkot
KARNATAKA
587315
India 
Phone  8861915770  
Fax    
Email  13.nikitam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukanya Patil 
Designation  Professor 
Affiliation  SDM Trusts Ayurvedic medical college Danigond Post graduation centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Dr Siddhant Nagar Terdal

Bagalkot
KARNATAKA
587315
India 
Phone  9480151454  
Fax    
Email  drsukanyapatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nikita M Magennavar 
Designation  PG Scholar 
Affiliation  SDM Trusts Ayurvedic medical college Danigond Post graduation centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Dr Siddhant Nagar Terdal

Bagalkot
KARNATAKA
587315
India 
Phone  8861915770  
Fax    
Email  13.nikitam@gmail.com  
 
Source of Monetary or Material Support  
SDM Trusts Ayurvedic medical college Danigond Post graduation centre 
 
Primary Sponsor  
Name  Dr Nikita M Magennavar 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital and Research Centre Dr Siddhant Nagar Terdal 587315 Bagalkot Karnataka  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikita M Magennavar  Padma Ayurvedic Hospital And Research Centre  OPD Department Of Prasuti Tantra Evum Stree Roga Ground Floor Padma Ayurvedic Hospital And Research Centre Terdal 587315
Bagalkot
KARNATAKA 		 8861915770

13.nikitam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:B373||Candidiasis of vulva and vagina. Ayurveda Condition: SLAISHMIKA-ASRUGDARAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  • Patients with Pratyatma Lakshana’s of Shweta Pradara tested positive for presence of Candida albicans through Wet Mount Microscopy
• Married women
• Subjects willing to sign the consent form
 
 
ExclusionCriteria 
Details  • Diagnosed case of PCOD, PID, UTI
• Patients with Systemic disorders like HTN, DM
• K/C/O Congenital abnormalities.
• K/C/O Thyroid and Parathyroid diseases, Malignancy
• Copper T and OCP using women, Pregnant and Lactating women
• K/C/O Cervical Erosion, Cervicitis
• K/C/O HIV, Hepatitis B, STD’s

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of trial drug in classical symptoms of Shweta Pradara w.s.r to Candida Vaginitis i.e.,
1. Srava(whiteDischarge).
2. Yonikandu(Itching).
3. Daurgandhya(FoulSmell).
4. Kati shoola(Backache).
5. Yoni vedana
 		 15th day, 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Safety of trial drug, adverse reaction & aggravation of symptoms of Shweta Pradara w.s.r Candida vaginitis  1st to 7th day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   30/10/2023 
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="0"
Months="10"
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  

·       Abnormal vaginal discharge is a frequent complaint of women seen in the gynecologic clinic. The discharge may range from excess of normal to one which is a part of wide spectrum of diseases. Candidavaginitis is caused by Candida albicans a gram - positive yeast like fungus. The patient complains of vaginal discharge with intense vulvovaginal pruritis. In Ayurveda, the word Shwetapradara has not appeared in the BruhatTrayis. Commentator Chakrapani, and Samhitas like Sharangadhra Samhita have used the word Shweta Pradara for white vaginal Discharges. Though Kaphadosha involvement is directly not mentioned but the characteristic clinical feature like Sneha, Sheeta, Shukla, Drava etc are that of Kapha thus Shweta Pradara is a Kaphaja Vyadhi. Since the pruritis is out of proportion to discharge this can be correlated to Candida vaginitis.

·      Panchavalkala Kashaya has been taken as standard drug and the combination of Guduchi, Triphala and Danti (Dantyadi) Kashaya is taken as trial drug as Dantyadi Kashaya contains the drugs that are mainly Tridoshahara, Krumighna, Vishaghna & Vedanasthapana. Here is an attempt to see and compare the effect of these formulations in management of Shweta Pradara (Candida vaginitis).

·       This is a randomized comparative clinical study. Total 40 patients of Shweta pradara who fulfills the Inclusion Criteria and having Classical sign and symptoms of Shweta pradara will be selected from the OPD and Medical camps conducted by SDM Trust’s Padma Ayurvedic Hospital and Research Centre, Terdal. These patients are randomly divided into two groups A and B. Group A will be given Dantyadi Kashaya yoniprakshalana and Group B given Panchavalkala Kashaya yoniprakshalana. Consent will be taken from patient and Case details will be recorded in separate case report form (CRF).  Total Study duration will be 30 days and contain 9 visits (0th– 7thday, 15th day, 30th day), which includes administration of trial drug for 7days and post medication follow up on 15th& 30th day. After study, data will be collected from case report form (CRF) and statistically analysed by using appropriate parametric and nonparametrictests and results will be obtained. On that basis of results, conclusion will be drawn.

·

 
Close