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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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N952||Postmenopausal atrophic vaginitis. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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
2Comparator Arm (Non Ayurveda)-Standerd controlMedicine 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
3Intervention ArmDrugClassical(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.

 
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