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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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Exercise induced Dehydration 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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.
2Comparator Arm (Non Ayurveda)-Mineral WaterMineral 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.
 
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. 
 
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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