| CTRI Number |
CTRI/2024/10/074616 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Shatavari treatment for women sexual wellness |
|
Scientific Title of Study
|
Shatavari In Women Sexual Wellness: A Prospective, Randomized, Double-Blind, Three-arm, Parallel, Placebo-Controlled, Efficacy and Safety Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SHT-1077-2024-02, Version 1; dt. 27th May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suprlya Mahajan |
| Designation |
Sr. Consultant |
| Affiliation |
Tieten Medi city Hospital |
| Address |
Tieten Medi city Hospital, gynecology division, 2nd floor, Ghodbunder Rd,
Kasarvadavali, Thane West, Thane, Maharashtra 40061
Thane
MAHARASHTRA
400610
India |
| Phone |
9930840246 |
| Fax |
|
| Email |
koltesupriya23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suprlya Mahajan |
| Designation |
Sr. Consultant |
| Affiliation |
Tieten Medi city Hospital |
| Address |
Tieten Medi city Hospital, gynecology division, 2nd floor, Ghodbunder Rd,
Kasarvadavali, Thane West, Thane, Maharashtra 40061
Thane
MAHARASHTRA
400610
India |
| Phone |
9930840246 |
| Fax |
|
| Email |
koltesupriya23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suprlya Mahajan |
| Designation |
Sr. Consultant |
| Affiliation |
Tieten Medi city Hospital |
| Address |
Tieten Medi city Hospital, gynecology division, 2nd floor, Ghodbunder Rd,
Kasarvadavali, Thane West, Thane, Maharashtra 40061
Thane
MAHARASHTRA
400610
India |
| Phone |
9930840246 |
| Fax |
|
| Email |
koltesupriya23@gmail.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 |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Supriya Mahajan |
Tieten Medicity Hospital |
Tieten Medi city Hospital, Ghodbunder Rd,
Kasarvadavali, Thane West, Thane, Maharashtra 400610
Thane
MAHARASHTRA |
9930840246
koltesupriya23@gmail.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 |
Women sexual wellness |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shatavari , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 300(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shatavari and Ashwagandha root extract ®, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 550(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: -), Additional Information: - | | 3 | Comparator Arm (Non Ayurveda) | | - | Identical Placebo capsule | Capsule containing starch 300mg |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1.Women between 18 to 55 years of age.
2.Women willing to have 4 or more attempts of sexual intercourse each month.
3.Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.).
4.Participants who are reliable, honest, compliant, and agree to co-operate with all trial evaluations as well as to be able to perform them as per investigator’s opinion.
5.Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
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 any active medical, surgical, or gynaecological problems.
4.Participants with a history of alcohol, tobacco dependence, or any other substance abuse
5.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.
6.Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
7.Participants with evidence of uncooperative attitude, including poor compliance.
|
|
|
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 scores for Female Sexual Function Index (FSFI) from baseline. |
Mean change in scores for Female Sexual Function Index (FSFI) from baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in scores for Satisfying Sexual Events (SSEs) from baseline. |
Baseline, Week 4, Week 8 |
| Mean change in scores for Female Sexual Distress Scale (FSDS) 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 |
| Mean change in Oxford Happiness Questionnaire (OHQ) scores from baseline. |
Baseline, Week 4, Week 8 |
| Mean change in Pittsburgh Sleep Quality Index (PSQI) Questionnaire 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 Thyroid (T3, T4, TSH) parameters from baseline. |
Baseline, Week 8 |
| Mean change in Renal (serum creatinine, blood urea nitrogen) 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="135"
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
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2024 |
| 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="2"
Days="25" |
|
Recruitment Status of Trial (Global)
|
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. · 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. · 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). The Adverse events, either spontaneously reported by the patient, or noticed by the clinician will be recorded during the study. |