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CTRI Number  CTRI/2025/04/085360 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 22/04/2025
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   Effect of Khadira suppository and clingen forte vaginal capsules in the management of vulvovaginitis during pregnancy 
Scientific Title of Study   Effect of Khadira suppository in the management of Upapluta Yoni Vyapath vis-a-vis vulvovaginitis in pregnancy-An open label standard controlled clinical study 
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 Sudharani 
Designation  PG Scholar 
Affiliation  JSS Ayurveda Medical college and Hospital, Mysuru 
Address  Department of PG studies in Prasuti Tantra and Stree Roga, Jss Ayurveda Medical College and Hospital, Lalithadripura road, Alanahalli, Mysuru, Karnataka

Mysore
KARNATAKA
570028
India 
Phone  6364690426  
Fax    
Email  sudharampure1997@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Usha D T 
Designation  Professor  
Affiliation  JSS Ayurveda Medical college and Hospital, Mysuru 
Address  Department of PG studies in Prasuti Tantra and Stree Roga, Jss Ayurveda Medical College and Hospital, Lalithadripura road, Alanahalli, Mysuru, Karnataka

Mysore
KARNATAKA
570028
India 
Phone  9164455019  
Fax    
Email  Usha.ayurveda@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Usha D T 
Designation  Professor  
Affiliation  JSS Ayurveda Medical college and Hospital, Mysuru 
Address  Department of PG studies in Prasuti Tantra and Stree Roga, Jss Ayurveda Medical College and Hospital, Lalithadripura road, Alanahalli, Mysuru, Karnataka

Mysore
KARNATAKA
570028
India 
Phone  9164455019  
Fax    
Email  Usha.ayurveda@gmail.com  
 
Source of Monetary or Material Support  
JSS Ayurveda Medical College and Hospital Mysuru 
 
Primary Sponsor  
Name  Dr Sudharani 
Address  JSS Ayurveda Medical College and Hospital Lalithadripura road, Alanahalli, Mysuru, Karnataka 570028 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
JSS Ayurveda Medical college and Hospital  41/E, Lalithadripura road, Alanahalli, Mysuru, 570028 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sudharani   JSS Ayurveda Medical College and Hospital  OPD No.9, Department of Prasuti Tantra and Stree Roga 41/E, Lalithadripura Road, Alanahalli, Mysuru, Karnataka
Mysore
KARNATAKA 
6364690426

sudharampure1997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N760||Acute vaginitis. Ayurveda Condition: UPAPLUTA/APLUTA, (2) ICD-10 Condition:N771||Vaginitis, vulvitis and vulvovaginitis in diseases classified elsewhere. Ayurveda Condition: UPAPLUTA/APLUTA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Khadira, Reference: P v Sharma, Dravya Guna Vignyana part 2, Chaukhambha Bharati Academy Varanasi, Pg no. 161, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 1(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: 1g of Khadira suppository will be inserted per vaginally once at bed time for 7 days.
2Comparator Arm (Non Ayurveda)-Clingen forte vaginal capsuleClingen forte vaginal capsule is a combination of Clindamycin, Clotrimazole and Tinidazole. Route-Vaginal dosage form-Suppository Dose-1 capsule Frequency-1 HS Duration-7 days
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  1.Pregnant women between the age group of 19 to 35 years, subjects having clinical features such as vaginal discharge, vulvar itching, burning sensation in vagina, pain in vagina, foul smell in vagina.
2.Pregnant women with irrespective of parity between 8 to 28 weeks of gestation
3.On pelvic examination inflammation Of vulva and vagina. 
 
ExclusionCriteria 
Details  1.Pregnant women with known case of medical disease such as Diabetes mellitus, hypertension, thyroid abnormalities, any organic pathology or hepatic, cardiac, renal disease or any acute infection.
2.Known case of Obstetric complications such as placenta Previa, cervical insufficiency and twin pregnancy.
3. History of previous abortion and known case of threatened abortion.
4. History of sexually transmitted diseases and known case of Human Immunodeficiency Virus.
5. Known case of congenital vaginal anomalies.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The effect of Khadira suppository in upapluta Yoni Vyapad.
The effect of clingen forte vaginal capsule in vulvovaginitis during pregnancy
The efficacy of Khadira suppository versus clingen forte vaginal capsule in vulvovaginitis during pregnancy 
1 week 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the disintegration time of trial suppository.  1 hour 
 
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)   05/05/2025 
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   Vulvovaginitis can be understand in Ayurveda with reference to Upapluta Yonivyapad. It is one among 20 Yonivyapad described by Acharya Charaka and both Vagbhata. Meaning of word Upapluta means over flowed, invade or afflicted. According to Ayurveda if women during pregnancy take Kapha aggravating Ahara and Vihara excessively and suppresses the urges of vomiting and respiration, the vitiated Vayu carries Kapha  to genital tract and affect the same, because of this, white mucus discharge along with pain occurs. There is prevalence of Kapha and Vata Rogas, termed as Upapluta Yonivyapad. 

Vulvovaginitis or vaginitis, is frequently cited as the most common reason that women visit their   primary care providers for a gynecologic-related diagnosis. It is defined as inflammation or infection of vagina, Vaginitis presents a spectrum of symptoms, including itching, burning, irritation, dyspareunia, vaginal odor, and abnormal vaginal discharge. The most common causes are Bacterial vaginosis, Vulvovaginal candidiasis, and Trichomoniasis.

Pregnancy is a immunocompromised state where there will be high chances for inflammation including vulvovaginitis. It occurs frequently during pregnancy because of altered vaginal flora. Vaginal infections are risk factors for premature rupture of membranes. Hence treating vaginal infections should done in priority along with regular antenatal care. Modern science has good treatment for Vulvovaginitis (local and oral). There is a need of good approach through Ayurveda.

Acacia catechu commonly known as Catechu is a medicinal plant used for varied purposes. The bark  of this plant is strong, antioxidant, astringent, antibacterial, anti-fungal, anti-viral and anti-inflammatory in nature.

Becomes because of its Tikta and Kashaya Rasa acts as Sthambhana, Kushtaghna and Krimighna.

Bark of Khadira has Kushtaghna and Kandughna properties.

Mainly used in Pradara and Yonishaithilya.

Khadira exhibits anti-bacterial and antifungal attributes, effectively impending the proliferation of bacteria and fungi, responsible for skin problems. The application or washing of affected area with Khadira Kwatha contributes to reducing inflammation and arresting bleeding, this is attributed to its Kashaya, Ropana and Krimighna properties.



 
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