| CTRI Number |
CTRI/2024/01/061524 [Registered on: 16/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Study the rehydrating effectiveness of Trushna-Nigrahana Mahakashaya in Exercise-induced Dehydration in healthy Individuals |
|
Scientific Title of Study
|
Evaluation of rehydrating efficacy of Trushna-Nigrahana Mahakashaya in Exercise-induced Dehydration in healthy Individuals |
| 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 Riddhi Sudhir Bhatt |
| Designation |
MD Scholar Department of Dravyaguna |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal |
| Address |
Room No. 226, PG Department of Dravyaguna, Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, Madhya Pradesh, India, 462003 Science Hills, Dhanvantari Marg, Bhopal, Madhya Pradesh, India, 462003 Bhopal MADHYA PRADESH 462003 India |
| Phone |
9824104299 |
| Fax |
|
| Email |
riddhi1802@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nitin Ujjaliya |
| Designation |
Assistant Professor ,Department of Dravyaguna |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal |
| Address |
Room No. 226, PG Department of Dravyaguna, Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, Madhya Pradesh, India, 462003 Science Hills, Dhanvantari Marg, Bhopal, Madhya Pradesh, India, 462003 Bhopal MADHYA PRADESH 462003 India |
| Phone |
8699327675 |
| Fax |
|
| Email |
drnujjaliya@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Riddhi Sudhir Bhatt |
| Designation |
MD Scholar Department of Dravyaguna |
| Affiliation |
Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal |
| Address |
Room No. 226, PG Department of Dravyaguna, Pt. Khushilal Sharma Government Autonomous Ayurveda College and Institute, Bhopal, Madhya Pradesh, India, 462003 Science Hills, Dhanvantari Marg, Bhopal, Madhya Pradesh, India, 462003 Bhopal MADHYA PRADESH 462003 India |
| Phone |
9824104299 |
| Fax |
|
| Email |
riddhi1802@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Government of India, New Delhi, India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No.-61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi, 110058 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Pt Khushilal Sharma Govt Autonomous Ayurveda College and Institute Bhopal |
Science Hills, Dhanvantari Marg, Bhopal, Madhya Pradesh, 462003 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Riddhi Sudhir Bhatt |
Pt. Khushilal Sharma Govt. (Autonomous) Ayurveda College and Institute, Bhopal |
Room No. 226, PG Department of Dravyaguna Bhopal MADHYA PRADESH |
9824104299
riddhi1802@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pt. Khushilal Sharma Government Ayurveda Institute, Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Exercise induced Dehydration |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trushna-Nigrahana Mahakashya, Reference: Charak Samhita Sutrasthana Adhyaya 4 , Route: Oral, Dosage Form: Phanta, Dose: 250(ml), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 1 Days, anupAna/sahapAna: No, Additional Information: Drug will be administered in four, 250 ml dosages, timed 4-7.5 minutes apart and will be served at room temperature. | | 2 | Comparator Arm (Non Ayurveda) | | - | Mineral Water | Mineral Water Dose: 250(ml), will be administered in four, 250 ml dosages, timed 4-7.5 minutes apart and will be served at room temperature. |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals aged between 20 to 35 years, who are apparently healthy, without any
discrimination of gender, caste and religion.
2. Individuals having their BMI between 18.5 kg/m2 and 24.9 kg/m2.
3. Individuals who will give written consent for study. |
|
| ExclusionCriteria |
| Details |
1. Individuals having any known systemic disorders, Diabetes Mellitus, Thyroid disorders, Gynaecological diseases, any metabolic disorders, musculoskeletal
disorders and any type of Cancers.
2. Individuals with a history of hypertension and participants who’s B.P during the initial screening on the day of study will be equal to or more than 140/90 mmHg and Pulse rate equal to or more than 100/minute.
3. Individuals who have undergone any surgery in the last 2 years.
4. Individuals who are on any kind of medications or are on any kind of a special diet.
5. Individuals who do extensive exercises on a regular basis.
6. Pregnant women and Lactating mothers.
7. Any other condition which can jeopardize the outcome of the research. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
At the end of the study, we would be able to evaluate the Rehydrating Efficacy of Trushna
Nigrahana Mahakashaya in Exercise-induced dehydration, in healthy individuals.
Objective Criteria:
1. Urine Volume
2. Urine Colour
3. Urine Specific Gravity
4. Serum Osmolality |
Analysis of data obtained before dehydration, immediately post dehydration,
and 90 minutes post-rehydration will be assessed and compared. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective criteria:
1. Thirst
2. Fatigue
3. Body weight |
Analysis of data obtained before dehydration, immediately post dehydration,
and 90 minutes post-rehydration will be assessed and compared. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
01/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Exhaustive physical work is common in athletes and certain occupations like firefighting which imposes considerable physiological demands, which is exacerbated by impaired heat dissipation due to environmental heat stress. Specifically, during moderate intensity exercise in the heat, sweatinduced water loss can be profound. Dehydration is an imbalance between fluid ingestion and loss, which may lead to dysfunction, illness, and likely increases susceptibility to heat related illness or injury. Fluid replacement before and during exercise is unlikely to be sufficient to counterbalance the ongoing fluid loss. This is especially true during prolonged exposure to a hot environment and in long duration games like Cricket, Football, Hockey etc. An athlete is then faced with the possibility of being significantly dehydrated when having to compete again soon. Also, not having enough hydration can have its effect on the athlete’s performance and not being able to perform as per one’s capacity leads to added amount of stress in their life. Hence, a decision must be made on the most effective post-exercise rehydration strategy to restore body fluid balance. If there is limited time (~2 hrs) before the next event, an athlete should replace fluid loss in order to achieve rehydration. The restoration of body fluid losses is necessary for optimal cardiovascular function and thermoregulation during subsequent exercise (Costill and sparks, 1973, Morimoto et al. 1983). One of the factors in achieving optimal post exercise rehydration is that drink volume should be greater than the volume of fluid loss. (Shirreffs et al., 1996). Drink palatability is important since an individual will not drink a sufficient quantity of drink he/she does not like (Hubbard et al. 1990). Rehydration after exercise requires not only replacement of volume loss but also replacement of electrolytes and primarily sodium lost in the sweat. Hence, the present study is taken up for evaluating the rehydrating efficacy of Trushna Nigrahana Mahakashaya in Exercise-Induced Dehydration.
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