| 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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (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. | | 2 | Comparator Arm (Non Ayurveda) | | - | Clingen forte vaginal capsule | Clingen 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
|
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|
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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.
|
|
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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
|
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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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