| CTRI Number |
CTRI/2025/07/091397 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| 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
|
Research to evaluate efficacy of Shatavaryadi Kashaya orally along with per vaginal application of Shatavari Ghrita ointment in the management of genitourinary syndrome of menopause and to compare its efficacy with standard treatment |
|
Scientific Title of Study
|
Efficacy of Shatavaryadi Kashaya along with Shatavari Ghrita ointment in the management of genitourinary syndrome of menopause - an open labelled randomised standard 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 |
Anjana Thanki |
| Designation |
1st year PhD Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda,Jamnagar |
| Address |
OPD 6, Department of PTSR, Institute of teaching and research in Ayurveda,Jamnagar,Gujrat 361008
Jamnagar GUJARAT 361008 India |
| Phone |
9898570854 |
| Fax |
|
| Email |
thankianjana22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Shilpa Donga |
| Designation |
Professor & HOD PTSR department |
| Affiliation |
ITRA,Jamnagar |
| Address |
504,Department of PTSR, Institute of teaching and research in Ayurveda,Jamnagar,Gujrat 361008
Jamnagar GUJARAT 361008 India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Shilpa Donga |
| Designation |
Professor & HOD PTSR department |
| Affiliation |
ITRA,Jamnagar |
| Address |
504,Department of PTSR, Institute of teaching and research in Ayurveda,Jamnagar,Gujrat 361008
Jamnagar GUJARAT 361008 India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of training and research in Ayurved,Jamnagar, 361008, India |
|
|
Primary Sponsor
|
| Name |
ITRA,jamnagar |
| Address |
Institute of training and research in ayurveda(INI), Opp B division police station, Jmanagar, 361008 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjana Thanki |
ITRA, Jamnagar |
OPD no 6, Prasutitantra evum streeroga vibhaga, ITRA hospital building, Jamangar Jamnagar GUJARAT |
9898570854
thankianjana22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N952||Postmenopausal atrophic vaginitis. Ayurveda Condition: RAJONASAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavryadi kashaya, Reference: shahastrayoga, Route: Oral, Dosage Form: , Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Prakshepa dravya - 5 ml go ghrita | | 2 | Comparator Arm (Non Ayurveda) | | - | Standerd control | Medicine name: Weltive 4G,Route:oral 1 capsule OD after food along with per vaginal application of evalon cream 0.5 mg twice/week at bed time will be given for 60 days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari ghrita ointment, Reference: AFI, Route: Vaginal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: hs, Bhaishajya Kal: Antarabhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Postmenopausal women (equal or more than 12 consecutive months since last menstrual period)
2.Age 40-65 years
3.Presence of at least 3 common symptoms of GSM i.e. Yoniraukshya, Yonikandu, Mutrakruccha, Mutradaha, Yonivedana, Yonidaha (vaginal dryness, vaginal itching, dysuria, burning micturition, dyspareunia, burning sensation per vagina).
4.Women with a confirmed diagnosis of menopause (natural- absence of menstruation for 12 months or more than that) or surgical- A history of bilateral oophorectomy or hysterectomy with or without bilateral salpingo-oophorectomy)
5.Willing to provide informed consent and comply with study protocol |
|
| ExclusionCriteria |
| Details |
1.Women under 40 or over 65 years of age.
2.Premenopausal women or those with irregular menstrual cycles.
3.Current use of systemic hormone replacement therapy (HRT) or vaginal estrogen treatments.
4.Active vaginal or severe urinary tract infections associated with fever, chills.
5.History of cervical, ovarian, endometrial, vaginal, vulvar and breast cancer.
6.Severe pelvic organ prolapses or other gynecological disorders requiring surgical intervention.
7.Current use of medications that affect sexual function or vaginal health(e.g,certain antidepressants, antihistamines).
8.Subjects with uncontrolled HTN (Blood Pressure equal or more than 150/100 mm of Hg) and Diabetes (RBS equal or more than 200 mg/dl) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the symptoms of Genitourinary Syndrome of Menopause (GSM), measured by standardized symptom scoring tools -Vaginal Health Index (VHI), Female Sexual Health Index (FSHI), Urinary tract infection symptoms assessment (UTISA) |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the vaginal maturity Index.
Improvement in Quality of life of postmenopausal women.
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
01/08/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Purpose of the research: Research of Genitourinary urinary syndrome of menopause can enhance early diagnosis, treatment options and overall management, leading to better health outcomes for women, particularly in aging populations. Addressing GSM can improve sexual health, reduce discomfort from urinary symptoms, and prevent complications like recurrent UTIs. Research on this topic is crucial to improving the quality of life for postmenopausal women. By focusing on the prevalence, impact, and treatment of this condition, especially in regions like India, we can reduce the underdiagnosis and undertreatment of GSM and provide better, culturally relevant care for women worldwide. Information on the Trial procedure and Drug: [Group A - Shatavaryadi Kashaya orally along with per vaginal application of Shatavari ointment Group B - Multivitamins supplement orally along with per vaginal application of estradiol ointment. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A. Description of the Process: In this present research work, 70 patients according to inclusion criteria will be selected and on the basis of computerized randomization, Patients will be divided into 2 groups, Group A: Deepana & Pachana with Guduchi, Haritaki and Sunthi Choorna will be given orally 3 days prior to administration of Shatavaryadi Kashaya. 20 gm of coarsely powdered drugs should be boiled with 16 parts of water in steel vessel, over a mild flame till the liquid is reduced to 1/4th of the original quantity. 40 ml of Shatavaryadi Kashaya with 5 ml of Goghrita Prakshepa will be given before meal to patient. 2-gram Shatavari ointment per vaginal application/ day at bedtime will be given to the patient. This treatment will be continued for 60 days. Drugs will be prepared in the Pharmacy of ITRA, Jamnagar. Group B: Multivitamins tablet and estriol ointment will be purchased from Pradhan Mantri Jan Aashaadha Kendra Jamnagar or other authentic medical store. Weltive 4G - Multivitamins tablet once/day after breakfast will be given to the patient along with estriol ointment 0.5 mg/twice a week will be advised to patients for 60 days. Follow-up: Patients will be advised to visit the hospital every 2 weeks during the treatment period (2 months). Follow up will be done for every 2 weeks after the completion of treatment to assess the status of the patient for 1 month. Side Effects: We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects.Results: The efficacy of the therapy will be assessed on the basis of subjective and objective criteria. Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Genitourinary syndrome of menopause. Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect. |