| CTRI Number |
CTRI/2026/01/100310 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Polyherbal formulation for management of menopausal symptoms] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to assess the safety and benefits of the PMS tablets in the treatment of menopausal symptoms in women. |
|
Scientific Title of Study
|
A Prospective, Open-Label, Single-Arm, Multiple-Center Clinical Study to Evaluate the Safety and Efficacy of PMS tablets in Subjects with Menopausal symptoms |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CTSRS/2520 Version No. 1.0 Dated 09 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi LM |
| Designation |
HOD-Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
09739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team Lead - Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
Clinical Research Unit, No.1204, "Ashva", 2nd Floor, 26th Main, Jayanagar 9th Block, Bangalore
Bangalore
KARNATAKA
560069
India |
| Phone |
06364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Vaidyarathnam Oushadhasala
Door No. 14/473/1, Thaikkattussery, Ollur, Thrissur, Kerala – 680306, India |
|
|
Primary Sponsor
|
| Name |
Vaidyarathnam Oushadhasala |
| Address |
Door No. 14/473/1,
Thaikkattussery, Ollur,
Thrissur, Kerala – 680306, 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 Sneha Bhoir |
Gayatri Hospital and ICU |
16/17/18, Ground Floor, Lavdeep Appartment Waliv, Near Navjeevan, Vasai (East) Palghar-401208
Palghar
MAHARASHTRA |
9340352659
gayatrihospital95@gmail.com |
| Dr Vinod Bharrati |
Rising Medicare Hospital |
Rising Medicare Hospital, No 105 Clinical Research Room, 1st Floor, Kharadi Bypass Road, Kharadi, Pune-411014
Pune
MAHARASHTRA |
9372030440
drvinodbharati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethicare Ethics committee |
Approved |
| Rising Medicare Hospital and IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N951||Menopausal and female climactericstates. Ayurveda Condition: RAJONASAH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: PMS Tabllets, 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: Warm Water), Additional Information: All subjects will receive the investigational product(PMS Tablets)to be taken at a dose of one tablet twice daily before food with warm water for duration of 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Females aged 40 to 60 years.
2. Perimenopausal or postmenopausal women with a history of menopausal symptoms for at least 1 month within the last 12 months.
3. Presence of moderate-to-severe menopausal symptoms defined as MRS score 9-15 is moderate and MRS score greater than or equal to 16 is severe.
4. Willing and able to provide written informed consent.
5. Willing to comply with study procedures and visit schedule. |
|
| ExclusionCriteria |
| Details |
1. History of psychiatric illness or alcohol dependence.
2. History of surgical menopause.
3. Current or past history of major systemic illness requiring long-term drug treatment (e.g., rheumatoid arthritis, psycho-neuro-endocrine disorders).
4. Current use of hormonal replacement therapy (HRT).
5. Known major organic pathology of the reproductive system (e.g., carcinoma, fibroids, ovarian cysts).
6. Use of any investigational drug within 1 month prior to randomization.
7. Known or suspected malignancy of any type.
8. Pregnant or lactating women.
9. Clinically significant abnormalities in Baseline laboratory values, including:
- Liver function-AST or ALT greater than 2.0 × ULN, total bilirubin greater than 1.5 × ULN (or greater than 2.0 × ULN unless known Gilbert’s syndrome).
- Renal function-eGFR less than 60 mL per min per 1.73 m-square or creatinine above normal range.
- Thyroid profile-TSH outside reference range or uncontrolled thyroid disease.
- Lipid profile-Triglycerides greater than or equal to 500 mg per dL or LDL-C greater than or equal to 190 mg per dL.
10. Abnormal vitals at Baseline-
- Systolic BP greater than or equal to 160 mmHg or Diastolic BP greater than or equal to 100 mmHg.
- Resting heart rate outside 50–100 bpm unless deemed clinically acceptable by the Investigator.
- Body temperature greater than or equal to 38.0 degree celsius.
11. Any acute illness or clinically significant abnormality on physical examination at Baseline, in the Investigator’s judgment.
12. Any other condition that, in the Investigator’s opinion, may interfere with study compliance, safety, or data interpretation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Menopausal Rating Scale (MRS) total score from Baseline (Day 0) to Day 90. |
Day 0 - Visit 1 - (Baseline)
Day 15 ±3 Days - Visit 2
Day 30 ±3 Days - Visit 3
Day 60 ±3 Days - Visit 4
Day 90 ±3 Days - Visit 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Symptom Reduction:
o Mean change in MRS total score from Baseline to Day 15, Day 30, and Day 60.
2. Quality of Life Improvements:
- Change in Utian Quality of Life (UQOL) scale score from Baseline to Day 90.
- Change in Menopause-Specific Quality of Life (MENQOL) scale score from
Baseline to Day 90.
3. Safety Assessments:
- Number, type, and severity of adverse events (AEs) and serious adverse events
(SAEs) throughout the study.
- Clinically relevant changes in laboratory parameters (Lipid profile, Thyroid profile,
LFT, RFT, Estrogen, FSH, LH) from Baseline to Day 90.
- Clinically significant changes in vital signs and physical examination findings during
the study period. |
Day 0 - Visit 1 - (Baseline)
Day 15 ±3 Days - Visit 2
Day 30 ±3 Days - Visit 3
Day 60 ±3 Days - Visit 4
Day 90 ±3 Days - Visit 5 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/01/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
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
|
Introduction:
Menopause is the natural cessation of menstruation, usually occurring between 45 and 55 years, with Indian women reported to experience menopause at a slightly younger age (mean ~46 years) compared with Western populations. Menopause is often accompanied with symptoms like hot flashes, night sweats, mood changes, sleep problems, and vaginal dryness. These symptoms can significantly affect a woman’s quality of life. While hormone replacement therapy (HRT) can help, its use is limited due to safety concerns. Many women seek safer alternatives, including Ayurvedic medicines. In Ayurveda, menopausal symptoms are described as Rajonivritti, linked to Vata and Pitta imbalances. Herbal ingredients used in Ayurvedic formulations—such as Shatavari, Ashoka, Bala, and Lodhra—may help restore balance, reduce symptoms, and improve well-being. PMS Tablets are a standardized Ayurvedic formulation designed to relieve multiple menopausal symptoms. Purpose of the Study:
This study aims to evaluate the safety and effectiveness of PMS Tablets in women with menopausal symptoms. It will assess improvements in symptoms and quality of life using validated tools (MRS, UQOL, MENQOL) and monitor safety through laboratory tests and adverse event reporting. The study intends to provide clinical evidence for PMS Tablets as a safe, effective, and holistic alternative to conventional therapies for menopause management. |