| CTRI Number |
CTRI/2023/08/056569 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluation of efficacy and safety of ASPURUS for management of menopausal symptoms |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of ASPURUS for management of menopausal symptoms (Hot Flushes, Anxiety, Stress, Sleep etc.,) and Regulation of HPO axis: A prospective, randomized, double-blind, multi center, placebo-controlled, interventional study |
| 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 G V Sugandha |
| Designation |
Consultant Obstetrician & Gynaecologist |
| Affiliation |
Good Life Hospital |
| Address |
OPD - Gynaecology,
Good Life Hospital,
Behind City Neuro Centre,
Kaleswararao Road,
Suryaraopet, Vijayawada
Krishna
ANDHRA PRADESH
520002
India |
| Phone |
7893062708 |
| Fax |
|
| Email |
drsugandhacr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nameet Baldwa |
| Designation |
COO |
| Affiliation |
Waleria Healthtech Pvt. Ltd. |
| Address |
Operations Depatment, D. No. 3-6-69/1, Avanti Nagar, Basheer Bagh, Hyderabad
Hyderabad
TELANGANA
500029
India |
| Phone |
9912777311 |
| Fax |
|
| Email |
nameet@waleriahealthtech.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamal Kammili |
| Designation |
Director - Operations |
| Affiliation |
Sanjeevani Bio Services Pvt. Ltd. |
| Address |
Office of Director - Operations, Plot No. 28B, Raghavendra Colony, Kondapur, Hyderabad
Hyderabad
TELANGANA
500084
India |
| Phone |
04048593559 |
| Fax |
|
| Email |
kamal.kammili@sanjeevanibio.com |
|
|
Source of Monetary or Material Support
|
| Waleria Healthtech Pvt. Ltd., |
|
|
Primary Sponsor
|
| Name |
Waleria Healthtech Pvt. Ltd., |
| Address |
3-6-69/1, Avanti Nagar, Basheer Bagh, Hyderabad - 500029 |
| 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 G V Sugandha |
Good Life Hospital |
OPD Room No.1, Gynecology Department,
Good Life Hospital,
Behind City Neuro Centre, Kaleswararao Road, Suryaraopet, Vijayawada
Krishna
ANDHRA PRADESH |
7893062708
drsugandhacr@gmail.com |
| Dr D Meenakshi Pranavi |
Ravi Nursing Home |
OPD Room No.3, Gynecology Department, Ravi Nursing Home, 4th Line, AT Agraharam, Guntur
Guntur
ANDHRA PRADESH |
9533116363
drctresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee - Fusion Clinical Research |
Approved |
| Independent Ethics Committee - Fusion Clinical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N95||Menopausal and other perimenopausal disorders. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari Churnam Capsule, Reference: Shastric Products, Route: Oral, Dosage Form: Churna/ Powder, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo Capsule | Each Placebo Capsule containes Micro Crystalline Cellulose Powder 250mg. The dose is one capsule after meals twice a day |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Female subjects aged 40 years to 65 years .
2. Subjects who are experiencing menopausal symptoms such as hot flushes, night sweats, anxiety, depression, insomnia etc., as diagnosed by the study investigator.
3. Subjects who are otherwise healthy except for the menopausal symptoms.
4. Subjects or their legally acceptable representative are willing to provide informed written consent and agree to adhere to the study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant, planning to become pregnant or breastfeeding women.
2. Subjects who have undergone partial or complete hysterectomy
3. Subjects who are undertaking hormone replacement therapy or any other herbal medicine treatment for menopausal symptoms.
4. Current or history of a serious illnesses in the last three months which as per the study investigator will impact the study outcomes.
5. History of or current Alcohol or substance abuse
6. Allergy or sensitivity to any of the ingredients in the study treatment
7. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly.
8. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in total score of Utian Quality of Life (UQOL) at day 30 & 60 as compared to baseline |
baseline, day 30 & day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in individual domain scores of UQOL at day 30 & 60 as compared to baseline |
baseline, day 30 & day 60 |
| Change in Menopause Symptom status, telephonically assessed using 5-pont Likert Scale at Day 7 & Day 14 & visit assessment at day 30 & day 60 as compared to baseline |
baseline, day 7, day14, day 30 & day 60 |
| Change in 21 item Depression, Anxiety & Stress Scale (DASS-21) Score at day 30 and 60 as compared to baseline |
baseline, day 30 & day 60 |
| Change in Regensburg Insomnia Scale score at day 30 & day 60 as compared to baseline |
baseline, day 30 & day 60 |
| Change in mean serum levels of estradiol & progesterone at day 60 as compared to baseline |
baseline, day 30 & day 60 |
| Satisfaction with treatment captured using Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ) at day 30 & day 60 |
day 30 & day 60 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 4 |
|
Date of First Enrollment (India)
|
23/08/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Menopause is defined as decreased ovarian follicular function and estrogen level, which may begin at mid-30s or late mid-50s. Approximately, 95% of the women in some communities are in menopause, and are predicted to reach 1.2 billion by 2030, with an annual increase of 47 million new cases.
Hormonal therapy and non-hormonal treatments (Anti-depressants) are intensive approaches to prevent and reduce menopausal symptoms that are accompanied by many adverse effects, including an increased risk of uterine & ovarian cancer and sleep disorders, dizziness, nausea, fatigue, etc. Women have been choosing alternative medicine since it’s affordable and safer. It boosts general health and reduces disease symptoms and ADR.
Shatavari (Asparagus racemosus Wild) has long been used as an Ayurvedic herb for women’s health, Steroidal saponins are thought to be the principal bioactive constituents of Shatavari root. Asparagus racemosus contains phytochemical constituents such as steroidal saponins, alkaloids, quercetin and glycosides of quercetin. In Ayurvedic medicine, it has been used to treat conditions relating to the female reproductive system including menopause, the immune system and the nervous system.
The purpose of this post marketing study is to investigate the safety and efficacy of Shatavari on reducing menopausal symptoms and regulating HPO Axis. |