| CTRI Number |
CTRI/2024/04/065706 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ashwagandha for Post-Menopausal Health: A Clinical Study |
|
Scientific Title of Study
|
Effect of Ashwagandha (Withania Somnifera) Root Extract on the Improvement of Health in Post Menopausal Women: A Prospective, Randomized, Double Blinded, Placebo-Controlled Clinical 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 |
Simran Obhrai |
| Designation |
Research Fellow |
| Affiliation |
MYAS-GNDU Department of Sports Sciences and Medicine |
| Address |
Biomechanics Laboratory, Ministry of Youth Affairs and Sports- Department of Sports Sciences and Medicine, Guru Nanak Dev University
DEXA lab, Health Center, Guru Nanak Dev University
Amritsar
PUNJAB
143005
India |
| Phone |
9760118899 |
| Fax |
|
| Email |
simranobhrai.sj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shweta Shenoy |
| Designation |
Professor and Dean |
| Affiliation |
MYAS-GNDU Department of Sports Sciences and Medicine |
| Address |
Cognition lab, MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University
Amritsar
PUNJAB
143005
India |
| Phone |
9760118899 |
| Fax |
|
| Email |
shweta.myas@gndu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Simran Obhrai |
| Designation |
Research Fellow |
| Affiliation |
MYAS-GNDU Department of Sports Sciences and Medicine |
| Address |
Biomechanics lab, Department of Sports Sciences and Medicine, Guru Nanak Dev University
Amritsar
PUNJAB
143005
India |
| Phone |
9760118899 |
| Fax |
|
| Email |
simranobhrai.sj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ashwagandha and placebo provided by Sandu Pharmaceuticals, Sandu Nagar, Mumbai- 400071 |
| DEXA Machine provided by Department of Sports Sciences and Medicine, Guru Nanak Dev University, Amritsar, Punjab- 143005 |
|
|
Primary Sponsor
|
| Name |
Simran Obhrai |
| Address |
MYAS-GNDU Department of Sports Sciences and Medicine, Guru Nanak Dev University |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MYAS GNDU |
Department of Sports Sciences and Medicine, Guru Nanak Dev University |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shweta Shenoy |
Guru Nanak Dev University |
DEXA lab, Health center, Guru Nanak Dev University, Amritsar
Amritsar
PUNJAB |
9501114472
shweta.myas@gndu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Guru Nanak Dev University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers will go through DEXA scan. The volunteers who are found to have osteoporosis/osteopenia without current pathological fracture will be included in the study. |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Placebo | Placebo tablets, reference- Sandu Pharma All the capsules used in this study (Placebo and 300mg Ashwagandha) are identical in appearance, shape, color, weight, and packaging. The placebo capsules contain starch as an inert filler | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha, Reference: Bhavaprakash Nighantu- page no. 379 and shloka no. 189-190, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: with milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Willing and able to give written informed consent for participation in the study
2. Age range 45-65 years
3. Post Menopausal status (defined by >1 yr since last menstrual period)
4. Ambulatory
5. Body mass Index (BMI) ≥18 and ≤32 kg/m2 at screening
6. Commitment to not use calcium or vitamin D supplementation that may influence the study outcome
7. Ability to understand and comply with the requirements of the study |
|
| ExclusionCriteria |
| Details |
1. Pre-menopausal or perimenopausal status or surgical menopause
2. History of chronic immunological or bone-related disorders, kidney disease, cardiovascular disease
3. History of bariatric surgery or other forms of malabsorption (including documented celiac disease or chronic diarrhoea)
4. Alcohol abuse
5. History of use of oral supplement products containing ashwagandha or Calcium, Vitamin D (more than once per week) within 4 weeks prior to baseline
6. Current use (within the past 8 weeks) of any medication with known influences on the immune or skeletal system (e.g. immune modulation therapy, systemic glucocorticoids, systemic steroid hormones)
7. Current or past use (within 1 year of starting the study) of denosumab, teriparatide, raloxifene, hormone replacement therapy, calcitonin, or any other anti-resorptive agent used for the prevention and treatment of osteoporosis.
8. Smoking or use of nicotine-containing products during the last 6 months
9. Uncontrolled thyroid disease (abnormal blood thyroid stimulating hormone level within the last 12 months and/or changing dose of thyroid replacement therapy within the last 12 months) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone mass density using DXA |
0 Month, 2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sleep Quality, General Wellness, liver function test |
before (Day 0) and After (Day 60-70) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/05/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| 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
Modification(s)
|
This prospective, randomized, double-blinded, placebo-controlled clinical trial aims to assess the effect of Ashwagandha root extract on postmenopausal women’s health. Participants will undergo baseline assessments, including DEXA scans, liver function tests, and serum calcium levels, before randomization to treatment or placebo. They will then consume 600mg or placebo tablets daily for three months, with monthly liver function tests to monitor safety. Changes in various health parameters will be evaluated pre- and post-intervention, with statistical analysis conducted on an intention-to-treat basis. |