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CTRI Number  CTRI/2025/03/082229 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
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   A clinical study to compare the effects of Satavari tablets and Amritadi tablets in Post Menopausal Syndrome. 
Scientific Title of Study   Efficacy of Amritadi formulation in Post Menopausal Syndrome: A Randomized Controlled 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  Dr Manju P M 
Designation  PG Scholar 
Affiliation  Govt. Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Trivandrum Kerala India. 695001 Thiruvananthapuram KERALA 695001 India

Thiruvananthapuram
KERALA
695001
India 
Phone  07907614004  
Fax    
Email  manjupadinjarappatt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M S Deepa 
Designation  Professor  
Affiliation  Government Ayurveda College Thiruvananthapuram 
Address  Department of Dravyagunavigyan Govt Ayurveda College Trivandrum Kerala India. Thiruvananthapuram KERALA 695001 India

Thiruvananthapuram
KERALA
695001
India 
Phone  9446171568  
Fax    
Email  drdeepamadhavank@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Asha Sreedhar 
Designation  Professor and HOD 
Affiliation  Government Ayurveda College Kannur 
Address  Department of Prasuti tantra and stree roga Government Ayurveda College kannur 670503 KERALA

Kannur
KERALA
670503
India 
Phone  9447893112  
Fax    
Email  drashaajith@gmail.com  
 
Source of Monetary or Material Support  
Govt. Ayurveda College Pulimood Junction Thiruvananthapuram 695001 
 
Primary Sponsor  
Name  Dr Manju P M 
Address  Manju P M Department of Dravyagunavigyan Govt. Ayurveda College Thiruvananthapuram kerala , pin 695001 
Type of Sponsor  Other [SELF] 
 
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 Manju P M  Govt Ayurveda College Thiruvananthapuram  Room No 1 Dravyaguna OP Department of Dravyagunavigyan Govt Ayurveda College Hospital Thiruvananthapuram KERALA
Thiruvananthapuram
KERALA 		 07907614004

manjupadinjarappatt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Govt. Ayurveda College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Amritadi , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: 2 tablets 500mg each administered twice daily
2Comparator ArmDrugOther than Classical(1) Medicine Name: Satavari Tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -2 tablets each of 500mg administered twice daily
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  Female in the age group 45 to 55 years diagnosed with Post Menopausal Symptoms according to Menopause Rating Scale with a score above 14. 
 
ExclusionCriteria 
Details  1.Artificial Post Menopause -surgical,radiation,iatrogenic Post menopause.
2.Any known case of malignancy.
3.Known Psychiatric disorders.
4.Those who had undergone hormone therapy within the past 3 months
5.Participants who have completed 5 years after menopause. 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in score as per MRS Scale (ordinal data)  Baseline, 61 -day, 91-day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in Psychological General Wellbeing Index(PGWBI),Greene Climacteric Scale(GCS),Menopause-specific Quality of Life Questionnaire (MenQOL)  Baseline, 61-day,91-day 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
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)   27/03/2025 
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="0"
Months="10"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  On personal contact via google drive

  6. For how long will this data be available start date provided 13-03-2025 and end date provided 30-11-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Post Menopausal syndrome, a complex and multifaceted condition, affects women during the natural transition from reproductive to non-reproductive years. It encompasses a variety of physical, psychological, and hormonal changes that can significantly impact a woman’s quality of life. The prevalence of Post Menopausal syndrome varies globally, with an estimated 25% of women experiencing severe symptoms that require medical intervention. Despite its prevalence, the syndrome is often underdiagnosed and undertreated, leading to unnecessary suffering for many women.In Ayurveda, the Menopausal period around the age of 50 is described as "Rajonivrithi" or "Rajakshaya," marking a transition from the pitta predominant middle stage of life (madhyamavastha) to the vata predominant elderly stage (vridhavastha). During this phase, there is a disturbance in the balance of pitta and kapha doshas, with vata dosha becoming dominant and there is a generalized Kshayavastha hence the line management is focussed on vatapittasamana, rasa rakta prasadana, balya and rasayana. In traditional Ayurvedic practice, Bala (Sida Cordifolia) and Satavari (Asparagus racemosus) are commonly utilized to alleviate Post Menopausal symptoms. This study is to determine the efficacy of the Amritadi tablet, in mitigating Post Menopausal symptoms, in comparison with the control group administered with Satavari tablet, when assessed using the Menopause Rating Scale (MRS). In this randomized controlled trial,76 Post Menopausal women between 45and 55 years, exhibiting Post Menopausal symptoms and scoring above 14 on the Menopause Rating Scale (MRS), will be recruited from the Govt. Ayurveda College Hospital, Thiruvananthapuram. Participants will be randomly allocated to receive either Amritadi tablet (2 tablets each, twice daily before food) or Satavari tablet (2 tablets each, twice daily before food) for 90 days. The primary endpoint will be the alteration in MRS scores, while secondary endpoints will encompass evaluations by the Greene Climacteric Scale (GCS), and Post Menopause-Specific Quality of Life (MENQOL), and Psychological General Wellbeing Index (PGWBI). The study is anticipated to provide data on the Amritadi formulation’s effectiveness in reducing vasomotor, somatic, psychological, and sexual symptoms of Post Menopause. The analysis will primarily focus on the differences in MRS scores from baseline through the treatment and follow-up stages. 
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