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CTRI Number  CTRI/2025/11/097657 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 09/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A CLINICAL TRIAL TO STUDY THE EFFICACY OF AYURVEDA VAGINAL SPRAY AND VAGINAL SUPPOSITORY AND ALLOPATHY VAGINAL SUPPOSITORY IN THE MANAGEMENT OF VAGINAL INFECTION 
Scientific Title of Study   EFFICACY OF XX VAGINAL SPRAY AND XX VAGINAL SUPPOSITORY IN THE MANAGEMENT OF ACHARNA YONI VYAPAT W S R TO VAGINAL MICROBIOTA DYSBIOSIS MULTI ARM RANDOMISED CONTROL CLINICAL TRIAL  
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 ANITA KUMARI UJJWAL  
Designation  Post graduate scholar Department of Prasuti tantra and Stri roga 
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan 302002 India
Department of Prasuti tantra and Str roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India 
Phone  7357569901  
Fax    
Email  ujjawalanita@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr POONAM CHOUDHARY  
Designation  Sr. Assistant Professor Department of Prasuti Striroga National Institute of Ayurveda, Jaipur  
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan 302002 India
Department of Prasuti tantra and Str roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India 
Phone  9352311106  
Fax    
Email  poonam.psr@nia.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr ANITA KUMARI UJJWAL  
Designation  Post graduate scholar Department of Prasuti tantra and Stri roga 
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawar singh gate Amer road Jaipur Rajasthan 302002 India
Department of Prasuti tantra and Str roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India
Jaipur
RAJASTHAN
302002
India 
Phone  07357569901  
Fax    
Email  ujjawalanita@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India  
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India  
Type of Sponsor  Research institution 
 
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 ANITA KUMARI UJJWAL  National Institute Of Ayurveda  Department of Prasuti tantra and stree roga 3rd floor room no 302 National Institute of Ayurveda jorawarsingh gate amer road Jaipur Rajasthan Jaipur RAJASTHAN 302002 india
Jaipur
RAJASTHAN 
07357569901

ujjawalanita@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE 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: ACARANA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: xx vaginal spray, Reference: NA, Route: Vaginal, Dosage Form: Sprays, Dose: 6(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: xx vaginal suppository, Reference: NA, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: -
3Comparator Arm (Non Ayurveda)-ALLOPATHIC VAGINAL SUPPOSITORYMedicine Name: CLINGEN vaginal suppository, Reference: NA, Route: Vaginal, Dosage Form: Suppository, Dose: 1(g), Frequency: od, TIMING OF ADMINISTRATION: EMPTY STOMACH, Duration: 7 Days
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Married Women with age group between 21 to 40 years diagnosed with Acharna yoni vyapat such as kandu and excessive vaginal discharge
Patients with abnormal Vaginal Microecology Evaluation System VMES 
 
ExclusionCriteria 
Details  Unmarried women
Pregnant women
Patients suffering from Sexually Transmitted Diseases which is evident from positive HIV VDRL HbsAg Anti HCV
Patient using oral contraceptive pills and IUCDs
Previous history of any major systemic illness such as Tubercular infections and uncontrolled diabetes mellitus
CIN II CIN III Cervical carcinoma
Associated with any gynaecological complications such as cervical fibroid large ovarian cyst and genital prolapse genital TB
Patient has received antifungal or antimicrobial therapy systemic or intra vaginal in
last one month  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary outcome: Change in VMES (Reduction in Excessive Vaginal Discharge Vaginal
Itiching and Burning Sensation) 
30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Quaility of Life   30 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 
Date of First Enrollment (India)   02/12/2025 
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="0"
Months="1"
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    Need of Study  In day to day practice the complaint of vaginal discharge is very common A change in the life style due to rapid urbanization  poor awareness emotional causes such as stress anxiety etc faulty dietary habits such as excessive use of tea coffee alcohol smoking etc higher antibiotics use birth control pills excessive work load unhygienic condition and individual habits like shame hesitation to submit to doctor etc  all contribute towards high incidences It is generally known that vaginal microbiota disturbance is highly related to various gynecological diseases especially Bacterial vaginosis  which is characterized by the alteration of vaginal microbiome from Lactobacillus dominance to anaerobic Bacterial vaginosis has been shown to be associated with various other reproductive tract disorders including infertility preterm cervical cancer and HIV acquisition (Leitich and Kiss 2007  van Oostrum et al  2013 Torcia, 2019) It is also reported that many sextually transmitted infections (STI) such as infections of N gonorrhoeae and C trachomatis are facilitated by vaginal microbiota dysbiosis It may also convert in chronicity which produces secondary complications Taking into account the complications of untreated vaginal discharges it therefore imperative that this condition be actively treated and quality of life restored
Rational for Selection of intervention/justification for Selection of trial drugs    Panchavalkala is one of the compound regimen popularly used and prescribed in the 6 classics for various gynecological disorders specially leucorrhoea uterine diseases and cervical erosions and also for wounds and ulcers in other parts of body The combination of the barks of 5 medicinal plants namely Vata (Ficus bengalensis) Udumbara (Ficus glomerata) Ashwatha ( Ficus religiosa ) Plaksha ( Ficus infectoria) Parisha ( Thespia populnea) in equal proporations is known as the Classical Panchavalkala Panchvalkala is having properties like Kashaya Rasa Sheetavirya Katuvipaka Panchvalkala have the best antibacterial and antifungal activity
Triphala is mild non habit forming and rejuvenative and hence recommenced for all It exhibits antiviral antibacterial antifungal antiallergic propertiesTriphala and its constituents act as improve blood circulation It shows immunomodulatory properties and helps in improving the body defence mechanism I have kashaya Rasa madhurvipaka Tridoshar Azadirachta indica is known to possess anti inflammatory antipyretic antimicrobial ant diabetic and diverse pharmacological properties It have Tikata kashaya Rasa laghu Guna Sheetavirya katuvipaka kandhughana prabhav  pitta kaphahar Dosha karma  Anti inflammatory and anti microbial activities of the root bark and leaves of A Indica Neem (Azadirachta indica) seed and leaf extracts have spermicidal anti microbial antifungal and antiviral properties They are also immuno modulatory that induce primarily a TH1 type response Honey has anti bacterial property Honey has well established function as an effective antibacterial agent with a broad spectrum of activity against Gram positive and Gram negative bacteria Some studies suggest that the topical use of honey may reduce odors swelling and scarring when used to treat wounds It have Madhura Rasa kasha anurasa ruksha Guna tridosha shamaka Sphatika has styptic and astringent properties It also acts as adjuvant It have kashaya kattu amala Rasa ushanavirya kandu tridoshanashak yonisankochak raktastravarodhaka
Haridra acts as an anti inflammatory antidiabetic anti diarrhoeal Hypolipidemic Hepatoprotective Anti cancerous It have Tikt Katu Rsa Ruksh  Laghu Guna Ushnavirya Katuvipak Kusthaghan Prabhav Kpha vat shamak dosha karma Vidanga is a useful herb to manage worm infestation that includes threadworms roundworms and types of worms due to its karimighna property It have Katu Kashya Rasa Laghu Ruksha Tikshna Guna Ushna virya Katu Vipaka Krimighna Prabhav Kapha Vatshamak dosha karma So In the present trial an attempt has been made to establish the efficacy of XX vaginal spray and XX Vaginal suppository in the management of acharna yoni vyapat w s r to vaginal microbiota dysbiosis
 
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