| CTRI Number |
CTRI/2024/10/074570 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Shatavari treatment for menopausal symptoms. |
|
Scientific Title of Study
|
Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women. A Randomized, Double-blind, Three arm, Parallel, Placebo-controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SHT-1076-2024-01, Version 1; dt. 27th May 2024. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashutosh Ajgaonkar |
| Designation |
Principal Investigator |
| Affiliation |
Trupti hospital |
| Address |
Trupti hospital, Devidaya Sociey Rd. Phase 1,
Devidaya Nagar, Thane West, Thane,
Maharashtra 400606
Thane
MAHARASHTRA
400606
India |
| Phone |
9757086159 |
| Fax |
|
| Email |
ashutosh.ajgaonkar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashutosh Ajgaonkar |
| Designation |
Principal Investigator |
| Affiliation |
Trupti hospital |
| Address |
Trupti hospital, Devidaya Sociey Rd. Phase 1,
Devidaya Nagar, Thane West, Thane,
Maharashtra 400606
Thane
MAHARASHTRA
400606
India |
| Phone |
9757086159 |
| Fax |
|
| Email |
ashutosh.ajgaonkar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Ajgaonkar |
| Designation |
Principal Investigator |
| Affiliation |
Trupti hospital |
| Address |
Trupti hospital, Devidaya Sociey Rd. Phase 1,
Devidaya Nagar, Thane West, Thane,
Maharashtra 400606
Thane
MAHARASHTRA
400606
India |
| Phone |
9757086159 |
| Fax |
|
| Email |
ashutosh.ajgaonkar@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Private Limited
Plot No-1057-F2, PBN Center, Road No. 45, Jubilee Hills Hyderabad, Telangana 500033 India |
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed Private Limited |
| Address |
Plot No-1057-F2, PBN Center,
Road No. 45, Jubilee Hills Hyderabad,
Telangana 500033 India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashutosh Ajgaonkar |
Trupti Hospital |
Trupti hospital, gynaecology division, 1st Floor, Devidaya Sociey Rd. Phase 1,
Devidaya Nagar, Thane West, Thane,
Maharashtra 400606
Thane
MAHARASHTRA |
9757086159
ashutosh.ajgaonkar@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee D Y Patil medical college Nerul Navi Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Menopausal women |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shatavari + Ashwagandha Root Extract, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Capsule containing starch 300mg | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shatavari, Reference: NA, Route: Oral, Dosage Form: Arishta, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Menopausal women aged 45 to 65 years with intact uterus and ovaries.
2.Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days
3.Females with complaints of menopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc.
4.Body mass index 18-35 kg/m2
5.Subject who has given written informed consent to participate in the study and understand the nature of the study
6.Able to read and write in English or any other vernacular language
7.No plan to commence new treatments over the study period.
8.Must have the ability and willingness to sign an informed consent and to comply with all study procedures.
|
|
| ExclusionCriteria |
| Details |
1.Participants taking any form of herbal extract in the last 3 months before study entry.
2.Participants who are on hormone replacement therapy (HRT) for more than 3 months.
3.Participants with Present active medical, surgical, and gynaecological problems.
4.Participants with a history of alcohol, tobacco dependence, or any substance abuse
5.Participants who had undergone bilateral ovariectomy
6.Participants with history of breast or cervical carcinoma
7.Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate.
8.Participants with Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult
9.Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
10.Participants with evidence of uncooperative attitude, including poor compliance.
11.Participants with inability to attend follow-up visit
12.Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective.
13.Patients with known hypersensitivity to Ashwagandha.
14.Patients who had participated in other clinical trials during the previous 3 months.
15.Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in score for Menopause Rating Scale (MRS) from baseline. |
Mean change in score for Menopause Rating Scale (MRS) from baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in scores for Perceived Stress Scale (PSS) questionnaire from baseline. |
Baseline, Week 4, Week 8 |
| Mean change in Menopause Symptoms Treatment Questionnaire (MENQOL) scores from baseline. |
Baseline, Week 4, Week 8 |
| Mean change in Profile of Mood States (POMS, abbreviated version) questionnaire scores from baseline. |
Baseline, Week 4, Week 8 |
| Proportion of women with improvement in Hot Flash (MRS scale) from baseline. |
Baseline, Week 4, Week 8 |
| Proportion of women with improvement in mood (MRS scale) from baseline. [Time Frame: Baseline, Week Proportion of women with improvement in mood (MRS scale) from baseline. |
Baseline, Week 4, Week 8 |
| Mean change in Serum hormones (Sr. Estradiol, FSH, LH, Testosterone) levels from baseline. |
Baseline, Week 8 |
| Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline. |
Baseline, Week 8 |
| Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline. |
Baseline, Week 8 |
| Mean change in Thyroid (T3, T4, TSH) parameters from baseline. |
Baseline, Week 8 |
| Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks. |
Baseline, Week 4, Week 8 |
| Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeks. |
Baseline, Week 4, Week 8 |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="90"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="25" |
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
|
· All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. · Subjects will be informed about the purpose of the study and signed informed consent will be taken. · Blood sampling for efficacy and safety parameters will be done at visit 1 (screening visit/ enrolment visit/ baseline visit- day 1) and visit 3 (week 8). · All subjects will be followed-up during the study period (visit 1 (screening visit/ enrolment visit/ baseline visit- day 1), visit 2 (week 4) ± 4 days, and visit 3 (week 8) ± 4 days. The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study. |