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CTRI Number  CTRI/2020/02/023338 [Registered on: 14/02/2020] Trial Registered Prospectively
Last Modified On: 09/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Role of shatavari in Rasa dhatu kshaya 
Scientific Title of Study   Role of shatavari in Rasa dhatu kshaya to establish the principle "सामान्यमेकत्वकरम्"(च.सू.1/४५) 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Urja Singh 
Designation  PG scholar 
Affiliation  Shubhdeep Ayurved Medical College Indore 
Address  Dept of Kayachitisa Room No 10 Shubhdeep Ayurved Medical College Gram Datoda Khandwa Road Indore MP

Indore
MADHYA PRADESH
452020
India 
Phone  8827216009  
Fax    
Email  drurjasingh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr AK Singh 
Designation  principal 
Affiliation  Shubhdeep Ayurved Medical college indore 
Address  Dept of Kayachikitsa Room No 10 Shubhdeep Ayurved Medical college gram Datoda Khandwa road Indore MP

Indore
MADHYA PRADESH
452020
India 
Phone  9630031233  
Fax    
Email  doctoraksingh@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Shrivastava 
Designation  Professor 
Affiliation  Shubhdeep Ayurved Medical college indore 
Address  Dept of RSBK Room no 41 Shubhdeep Ayurved Medical college gram Datoda Khandwa road Indore MP

Indore
MADHYA PRADESH
452020
India 
Phone  8982394425  
Fax    
Email  drshrivastava.akhilesh@gmail.com  
 
Source of Monetary or Material Support  
Dr Urja Singh PG Scholar Shubhdeep Ayurved Medical College Indore MP 452020 
 
Primary Sponsor  
Name  Shubhdeep Ayurved Medical College 
Address  Shubhdeep Ayurved Medical College and Hospital – PG Institute, Gram Datoda, Khandwa Road, Indore (M.P.) 452020. 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Urja Singh  Shubhdeep Ayurved medical college indore  Dept of kayachikitsa Room no 10 Shubhdeep Ayurved Medical College and Hospital – PG Institute, Gram Datoda, Khandwa Road, Indore (M.P.) 452020.
Indore
MADHYA PRADESH 		 8827216009

drurjasingh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee shubhdeep ayurved medical college indore   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: R538||Other malaise and fatigue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Shatavari churna  Administered Shatavari Churna 5 gm bd with milk and will be assessed on 15th and 31st day.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Age between 16 to 50 years.
2.Patients fulfilling the description of Rasa Dhatu Kshay.
3.Patients having BMI less than or equal to 18.5 Kg/m2.
4.Patients of either sex.
 
 
ExclusionCriteria 
Details  1.Patients below 16 years and above 50 years of age.
2.Patients suffering from infectious disease like TB, AIDS.
3.Endocrinological disorders like Juvenile DM, Hyperthyroidism, Severe Cardiac Problem.
4.Congenital and hereditary problems like Down’s syndrome, Thalassemia.
5.Malignancies.
6.Pregnant and Lactating women.
7.Unwilling to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A. Subjective Criteria - The score of symptoms will be assessed before and after the treatment and statistical analysis will be undertaken.
1.Twag Rookshata (Dryness of Skin)
2.Shram (Fatigue)
3. Shosh (Emaciation)
4. Hrid Spandan (Palpitation)
5.Shabd Asahishnuta (Irritated to loud sound)
6.Trishna (Excessive Thirst)
7.Shool (Bodyache)
B. Objective Criteria: -
1. BMI
2. Haemoglobin percentage will be checked before and after the treatment.

 		 30 th day 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   14/02/2020 
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)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

                          Ayurveda defines health as a state of equilibrium of Doshas, Agni, Dhatus and Malas as well as the mind and soul must be in pleasant state. The decrease in quantity of first and foremost Dhatu leads to the diseased conditions with symptoms like generalised weakness, emaciation, fatigue, palpitations and irritated to loud sound. This diseased situation and it’s classical symptoms are mentioned in classical texts. 

           Shatavari is an excellent medicinal herb which acts directly on Rasa Dhatu due to it’s similarities with the qualities of the Dhatu. The results of this medicinal herbs will be observed on patients with general debility.                              Weakness and emaciation is the most common problem found in all age groups irrespective of disease. It’s ultimate cause is Rasa Dhatu Kshay. The need of the study is to combat with this common problem with the help of widely available, economical and easily ingestible drug. Not only Shatavari will treat the symptoms of Rasa Dhatu Kshay but will also rejuvenate the body of the patient because of it’s excellent Rasayana properties.

 
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