| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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: - | | 2 | Comparator Arm | Drug | Other 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: - | | 3 | Comparator Arm (Non Ayurveda) | | - | ALLOPATHIC VAGINAL SUPPOSITORY | Medicine 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 |