| CTRI Number |
CTRI/2024/02/062379 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [improving endurance ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of homoeopathic medicine Withania somnifera 6C in improving cardiac endurance |
|
Scientific Title of Study
|
A single-blind parallel arm randomized placebo-controlled trial on the effect of Withania somnifera 6C in improving cardiorespiratory endurance in children undergoing athletic training |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abina Augustine |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Depatment of Paediatrics
Sarada Krishna homoeopathic medical college
Kulasekharam
Kanniyakumari dist
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9496718901 |
| Fax |
04651279448 |
| Email |
abinaaugustine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P R Sisir |
| Designation |
HOD and professor |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Depatment of Paediatrics
Sarada Krishna homoeopathic medical college
Kulasekharam
Kanniyakumari dist
TAMIL NADU
629161
India |
| Phone |
6282615250 |
| Fax |
04651279448 |
| Email |
hodpd@skhmc.org |
|
Details of Contact Person
Public Query
|
| Name |
Abina Augustine |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic medical college |
| Address |
Depatment of Paediatrics
Sarada Krishna homoeopathic medical college
Kulasekharam
Kanniyakumari dist
TAMIL NADU
629161
India |
| Phone |
9496718901 |
| Fax |
04651279448 |
| Email |
abinaaugustine@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna homoeopathic medical college |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic medical college |
| Address |
Sarada Krishna Homoepathic medical college
Kulasekharam
Kanniyakumari dist
|
| Type of Sponsor |
Private medical college |
|
|
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 |
| Abina Augustine |
Sarada Krishna Homoeopathic medical college hospital and peripheral centers |
Department of paediatrics
Sarada Krishna Homoeopathic medical college
Kulasekharam
Kanniyakumari dist
Kanniyakumari
TAMIL NADU |
9496718901
04651279448
abinaaugustine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sarada Krishna Homoeopathic medical college Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Improving cardiorespiratory endurance |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Unmedicated pills |
30 size pills will be given to 15 subjects including both male and female and advised to take 3 pills on alternate days for 3 months |
| Intervention |
Withania somnifera |
medicated 30 size pills will be given to 15 subjects including both male and female and advised to take 3 pills on alternate days for 3 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Only children of age group between 12 and 18 years of age
Children who are healthy, not under any medications
Children interested in regular athletic training
|
|
| ExclusionCriteria |
| Details |
Children above 18 years and below 12 years of age
Children with any cardiorespiratory illness rheumatic complaints and other systemic illness
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement of cardiorespiratory endurance and fitness index |
initial visit and after 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in hemoglobin value |
initial visit & after three months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
05/08/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/08/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Professional athletes face challenges like exhausting training or
intensive competition to push their bodies beyond our imagination. To prevent
and recover from mental and physical health problems regular exercise,
especially moderate or vigorous-intensity aerobic activity is important but at
some instance this intense exercise can actually compromise health. Ashwagandha, otherwise known as Indian ginseng or poison gooseberry,
belongs to the Solanaceae family. In addition to its adaptogenic properties,
there are multiple medicinal benefits including antitumor, anti-inflammatory,
hypoglycemic and antioxidant effects has been studied. The wide structural
variety of withanolides might be related to the multiple biological functions
that have been described for Ashwagandha: antimicrobial, anti-inflammatory,
immunomodulatory, neuroprotective, cytotoxic, and antioxidant, etc. Homoeopathy has
shown its effectiveness in many fields but there aren’t much studies in the
field of sports. For an athlete the most important part is improving their
performance in the competition. But it is not an overnight process behind
winning. They take a lot of effort and the main part is improving their
stamina. It includes both mental and physical ability to sustain the activity
for a long time. Homoeopathy can improve the general health and can also
improve the performance of athletes performance.Study will be on
subjects of 18 years and below. The sample will be selected through school
health programmes and other volunteers from SKHMC. The total samples will be
30. Samples will be stratified based on age and sex. They will be divided into
placebo group and medicinal group. Assessments like Height, Weight, exhaustion
time, fitness index and VO2 max will be done before starting the study. These
parameters will be obtained through Harvard step test and their CBC will also
be assessed. At the initial month they
will be given regular exercise on a daily basis. Then for the next 3 months the
samples will be divided into 2 groups, one group will be given placebo and the
other group will be given Withania somnifera 6C on a random basis. Every
subject will be adviced to take a proper diet. At the beginning of the 4th
month again the fitness index will be calculated along with VO2max and
exhaustion time along with CBC. The result will be obtained using paired t test,
Chi-square test and correlation analysis. |