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CTRI Number  CTRI/2024/08/072177 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 27/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Triphala Kashaya Yoni Prakshalana With And Without Gomutra Arka In Vaginal Candidiasis  
Scientific Title of Study   An Open-Label Double-Arm Randomized Clinical Trial To Compare The Effect Of Triphala Kasaya Yoniprakshalana With And Without Gomutra Arka In Vaginal Candidiasis (Slaismiki Yonivyapad) 
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 C Roshini 
Designation  PG Scholar 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Stri roga and Prasuti Tantra Amrita School of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Clappana P.O.

Kollam
KERALA
690525
India 
Phone  8217453249  
Fax    
Email  roshinisekhar1997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr C Roshini 
Designation  PG Scholar 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Stri roga and Prasuti Tantra Amrita School of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Clappana P.O.


KERALA
690525
India 
Phone  8217453249  
Fax    
Email  roshinisekhar1997@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Parvathy Unnikrishnan 
Designation  Associate Professor 
Affiliation  Amrita School Of Ayurveda 
Address  Department of Stri roga and Prasuti Tantra Amrita School of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Clappana P.O.

Kollam
KERALA
690525
India 
Phone  9497882774  
Fax    
Email  dr.parvathy@ay.amrita.edu  
 
Source of Monetary or Material Support  
Amrita School Of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Clappana P.O Kerala,India- 590525 
 
Primary Sponsor  
Name  Dr C Roshini 
Address  Department of Stri roga and Prasuti Tantra Amrita School of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Clappana P.O. Kerala India – 690 525.  
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 C Roshini  Amrita School Of Ayurveda  Stri roga and Prasuti Tantra OPD Department of Stri roga and Prasuti Tantra Amrita School of Ayurveda Amrita Vishwa Vidyapeetham Amritapuri Clappana P.O.
Kollam
KERALA 		 8217453249

roshinisekhar1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amrita School of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: KAPAJA-YONIROGAH, (2) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: KAPAJA-YONIROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-yoni dhAvana, योनि धावन (Procedure Reference: Ashtanga sangraha uttarasthana 39th chapter 49th sloka, Procedure details: vaginal douche)
(1) Medicine Name: Triphala kashaya, Reference: charaka chikitsa 30th chapter, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days
2Intervention ArmProcedure-yoni dhAvana (Procedure Reference: Ashtanga sangraha uttarasthana 39th chapter 49th sloka, Procedure details: vaginal douche)
(1) Medicine Name: Triphala Kasaya Gomutra Arka, Reference: Charaka chikitsa 30th chapter rasatantrasara siddhayoga sangraha pradhama khanda, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 1000(ml), Frequency: od, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  1.Female aged 18- 45yrs.
2.Patients diagnosed with candidiasis with the presence of hyphae/spores in KOH Wet mount test. 
 
ExclusionCriteria 
Details  1.Pregnancy.
2.Known case of diabetes mellitus.
3.Known case of STD/PID.
4.Known case of malignancies.
5.Under OCP.
6.Under antibiotics
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.Reduction of spore count using KOH Wet mount test.
 		 Reduction of spore count using KOH Wet mount test-day-0,3,5 & 8
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in pruritus using 5-D itch scale
Reduction in Vaginal discharge using Discharge scale 		 Reduction in pruritus using 5-D itch scale- day-0,3,5 & 8
Reduction in Vaginal discharge using Discharge scale-day-0,3,5 & 8 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/08/2024 
Date of Study Completion (India) 30/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Vaginal candidiasis also known as Moniliasis is caused by Candida albicans, a gram-positive yeast-like fungus. Ayurvedā literature explains the diseases of the female reproductive system under Yonivyāpad. ÅšlaiÅ›mikÄ« Yonivyāpad exhibits, similar clinical symptoms of vaginal candidiasis. The main symptoms are picchilā, śītala srāva from yoni along with kaṇḍu, alpavedanā and avedanā. Vaginal candidiasis clinically, produces symptoms of excessive vaginal discharge which is thick, curdy white, cotton cheese type and in flakes, along with pruritis and vaginal irritations. The untreated vaginal infections can lead to complications like infertility, pre-term birth, miscarriages and other infectious diseases.Due to these adverse effects on the reproductive health and well-being of women, vaginal infections have become a major public health concern all over the globe. In these conditions, effective, complete, safe and timely management of the pathogenic fungi is a must. In Ayurvedā, the treatment modality mentioned by Acharya for ÅšlaiÅ›mikÄ« Yonivyāpad are ruksa and usna cikitsā. In Caraka saṃhitā and Aṣṭāṅga sangraha, the use of Triphalā Kaṣāya along with Go mutrā/takrā/suktā in the context of srāva pradhāna yoni rogā is mentioned.Yoni prakśālanā with Triphalā Kaṣāya is clinically effective in Vaginal candidiasis. But there are no studies conducted clinically, showing the effect of combination of Triphalā Kaṣāya and Go mutrā Arka in the management of Vaginal candidiasis. So, this study aims to investigate the effectiveness of adding GomÅ«tra Arka to Triphalā Kaṣāya for treating Vaginal candidiasis. 

With the permission of the Institutional Ethics Committee & after Registration at CTRI 36 participants will be selected from OPD & IPD of Amrita Ayurveda Hospital satisfying the Inclusion criteria. After taking informed consent, vaginal candidiasis will be assessed using assessment tools. The participants were allocated into 2 groups using simple random method sampling (chit method). Group A receives Triphalā Kaṣāya Yoniprakṣālana and Group B receives Yoniprakṣālana with Triphalā Kaṣāya and Gomūtra Arka for 7 days.

 
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