| CTRI Number |
CTRI/2024/05/067423 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on Vimosa Softgel in vaginal dryness and vaginal prolapse |
|
Scientific Title of Study
|
Clinical study to evaluate efficacy and safety of Vimosa softgel capsule in vaginal dryness and vaginal prolapse – An open label, single arm, multi-center, interventional, prospective, clinical study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AHPPL/VDVP/VIMO/2024, Version 1.0, 24th Feb 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Jadhav |
| Designation |
Associate Professor |
| Affiliation |
Ayurved Seva Sangh,Ayurved Mahavidyala, Ganeshwadi, Nashik |
| Address |
Department of Prasuti Tantra Department, OPD No. 5, Ground Floor, Ayurved Seva Sangh’s, Ayurved Mahavidyalaya & Rugnalaya, Ganeshwadi, Panchvati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
7775058616 |
| Fax |
|
| Email |
archujadhav88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Abhinav Health Care Products Pvt Ltd
Registered office- 100,
Jankidevi School Road,
MHADA, Four Bunglows,
Andheri West Mumbai 400053, India |
|
|
Primary Sponsor
|
| Name |
Abhinav Health Care Products Pvt Ltd |
| Address |
100,Jankidevi School Road,
MHADA, Four Bunglows,
Andheri West Mumbai 400053, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mangesh Patil |
Dr G. D. Pol Foundation YMT Ayurvedic Medical College & Hospital. P. G. Institute. |
Department of Prasuti Tantra Department, OPD No. 3, Ground Floor, Dr G. D. Pol Foundation
YMT Ayurvedic Medical College & Hospital. P. G. Institute.
Institutional Area, Sector 4, Kharghar, Navi Mumbai, Maharashtra, India – 410210
Mumbai
MAHARASHTRA |
9320380219
drmangeshpatil21@gmail.com |
| Dr Archana Jadhav |
Ayurved Seva Sangh’s, Ayurved Mahavidyalaya & Rugnalaya |
Department of Prasuti Tantra Department, OPD No. 5, Ground Floor,
Ayurved Seva Sangh’s, Ayurved Mahavidyalaya & Rugnalaya, Ganeshwadi, Panchvati, Nashik – 422003
Nashik
MAHARASHTRA |
7775058616
archujadhav88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ayurved Seva Sangh Ayurved Mahavidyalaya, Nashik |
Approved |
| Institutional Ethics Committee, Dr G.D.Pol Foundation YMT Ayurvedic Medical College & Hospital. P. G. Institute. |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N814||Uterovaginal prolapse, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: VIMOSA SOFTGEL CAPSULE, Reference: NA, Route: Vaginal, Dosage Form: Capsules, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Samudga, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Cohort 1:
The duration of treatment will be 30 days.
Cohort 2:
Duration of treatment will be 90 days
Direction for Use for both the cohorts:
Subjects will be provided the following instructions on the method of using Vimosa SGC on their own.
Wash & clean hands. VIMOSA Soft Gel Capsule has to be removed from the blister pack. If required wet and moist the Capsule with water (by immersing it in a glass of wa | | 2 | Comparator Arm (Non Ayurveda) | | - | NIL | NIL |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Cohort 1
1. Female subjects (21 to 70 years) with symptoms of vaginal dryness due to various causes including reduced secretory function of the vaginal epithelium, anti-estrogen medications, hormonal therapy, use of scented or perfumed soaps, sprays and washes around or in vagina, removal of ovaries etc.
2. A negative urine pregnancy test for all female subjects unless patient has had a hysterectomy, tubal ligation, or is greater than 2 years post menopause.
Cohort 2
1 Females (30 to 60 years) with first or second degree uterovaginal prolapse
2.A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is greater than 2 years post menopause.
|
|
| ExclusionCriteria |
| Details |
Cohort 1:
1. Patients with vaginal infections such as trichomonas, candida & bacterial vaginosis (BV).
2. Subjects who are known cases of Diabetes having uncontrolled blood sugar levels (fasting blood sugar levels NMT 250 mg per dl and HbA1c NMT 8 percent)
3. Patients with breast cancer, uterine cancer and genital bleeding of unknown origin.
4. Patients using medications (internally and externally) that promote healing
5. History of Use of any other investigational product within 1 month prior to randomization
6. Known history of hypersensitivity to ingredients used in study product
7. Pregnant and breast-feeding women
Cohort 2:
1. Patients with Procidentia, congenital elongation of cervix, cervical fibroid, polyp, chronic inversion of uterus.
2. Patients who have been advised to undergo surgical removal of uterus or surgical treatment for Utero-vaginal prolapse
3. Subjects who are known cases of Diabetes having uncontrolled blood sugar levels (fasting blood sugar levels NMT 250 mg per dl and HbA1c NMT 8 percent)
4. Patients with uterine cancer and genital bleeding of unknown origin.
5. Patients with known history of significant cardiovascular event 12 weeks prior to randomization.
6. History of Use of any other investigational product within 1 month prior to randomization
7. Known history of hypersensitivity to ingredients used in study product
8. Pregnant and breast-feeding women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cohort 1: Change in Vaginal dryness using VAS.
Cohort 2:
Change in mass per vaginum
|
Cohort 1: Screening or Baseline visit (Day 0), Visit 1 (Day 15) and Visit 2 (Day 30)
Cohort 2: Screening or Baseline visit (Day 0). Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cohort 1:
1. Change in itching, dyspareunia, burning, painful sex as assessed using VAS
2. Change in pH of vagina.
3. Change in quality of life as assessed using WHO QOL BREF
4. Assessment of requirement of rescue medications
5. Global assessment of overall change as assessed by investigator and subjects
6. Assessment of tolerability of the study product
7. Assessment of adverse events and vitals
Cohort 2:
1. Changes in urinary incontinence, backache and lower abdominal discomfort
2. Change in Pelvic Floor Distress Inventory Questionnaire (PFDIQ-20)
3. Change in quality of life as assessed using WHO QOL BREF
4. Assessment of requirement of rescue medications
5. Change in global assessment for overall change by subject and investigator
6. Assessment of tolerability of the study product
7. Assessment of adverse events and vitals
|
Cohort 1: Screening or Baseline visit (Day 0), Visit 1 (Day 15) and Visit 2 (Day 30)
Cohort 2: Screening or Baseline visit (Day 0). Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90) |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
19/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
Modification(s)
|
It is an open label, single arm, multi-center, interventional, prospective, clinical study to evaluate efficacy and safety of VIMOSA SOFTGEL CAPSULE in Vaginal Dryness and Vaginal Prolapse. The study will be carried out in 2 to 3 centers in India. There will be two cohorts in the study. In cohort I, subjects of vaginal dryness will be recruited and they will be asked to use VIMOSA Soft Gel Capsule once daily at night while going to bed for 30 days. In Cohort 2, subjects of uterine prolapse will be recruited and they will be asked to use VIMOSA Soft Gel Capsule once daily at night while going to bed for 90 days. The primary objective of Cohort I will be to assess change in Vaginal dryness using VAS on screening or baseline visit (Day 0), Visit 1 (Day 15) and Visit 2 (Day 30). The primary objective of cohort 2 will be to assess change in mass per vaginum from on screening or baseline visit (Day 0). Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90). The secondary objectives of the cohort 1 will be to assess change in itching, dyspareunia, burning, painful sex as assessed using VAS, change in pH of vagina, change in quality of life as assessed using WHO QOL BREF, requirement of rescue medications, global assessment of overall change as assessed by investigator and subjects, tolerability of the study product and adverse events and vitals on screening or baseline visit (Day 0), Visit 1 (Day 15) and Visit 2 (Day 30). The secondary objectives of the cohort 2 will be to assess changes in urinary incontinence, backache and lower abdominal discomfort, change in Pelvic Floor Distress Inventory Questionnaire (PFDIQ-20), change in quality of life as assessed using WHO QOL BREF, requirement of rescue medications, change in global assessment for overall change by subject and investigator, tolerability of the study product and adverse events and vitals screening or baseline visit (Day 0). Visit 1 (Day 30), Visit 2 (Day 60), Visit 3 (Day 90).
Results and Observations:
Cohort 1:
The study concludes that use of Vimosa soft gel
capsules helped significantly in reducing Vaginal dryness with 15 days which
continued further till 30 days. Other symptoms associated with dryness like
itching burning sensation and pain also showed significant reduction. There was
an improved libido and increased sexual satisfaction with the use of Vimosa
soft gel capsules. No adverse events were reported with the regular use of
Vimosa Soft Gel capsules. A significant improvement in quality of life was also
observed with the use of Vimosa SGC.
Cohort 2:
In
participants suffering from mild to moderate uterine-vaginal prolapse there was
a significant reduction with a shift from moderate to mild and mild to no
prolapse with the use of Vimosa soft gel capsules over a period of 90 days.
Other symptoms associated with prolapse like urinary incontinence, backache and
abdominal pain also showed significant reduction over the study period. Vimosa
SGC were well tolerated for long term use over 90 days without producing any
adverse effects. A significant improvement in quality of life was also observed
with the use of Vimosa SGC. |