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CTRI Number  CTRI/2021/02/031087 [Registered on: 08/02/2021] Trial Registered Prospectively
Last Modified On: 04/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Single Arm Study 
Public Title of Study   EFFEFT OF AUSHADHI PANCHAMRITA IN OJAKSHAYA 
Scientific Title of Study   A PHYSIOLOGICAL STUDY OF OJAS AND TO EVALUATE THE EFFICACY OF “AUSHADHI PANCHAMRITA YOGA” IN OJAKSHAYA 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR SANGEETA SINGH 
Designation  M.D. SCHOLAR 
Affiliation  University College of Ayurveda Dr.SRRAU JODHPUR, RAJASTHAN  
Address  P.G. Department of Kriya Sharir University College of Ayurveda Dr.SRRAU JODHPUR, RAJASTHAN
University College of Ayurveda Dr.SRRAU JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342037
India 
Phone  6375900945  
Fax    
Email  drsangeetasingh1992@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR RAJESH KUMAR SHARMA 
Designation  ASSOCIATE PROFESSOR AND HOD 
Affiliation  P.G. Department of Kriya Sharir, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University 
Address  P.G. Department of Kriya Sharir, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Nagaur Road, Jodhpur

Jodhpur
RAJASTHAN
342037
India 
Phone  9413324758  
Fax    
Email  drrajesh243@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR SANGEETA SINGH 
Designation  M.D. SCHOLAR 
Affiliation  University College of Ayurveda Dr.SRRAU JODHPUR, RAJASTHAN  
Address  P.G. Department of Kriya Sharir University College of Ayurveda Dr.SRRAU JODHPUR, RAJASTHAN
University College of Ayurveda Dr.SRRAU JODHPUR, RAJASTHAN
Jodhpur
RAJASTHAN
342037
India 
Phone  6375900945  
Fax    
Email  drsangeetasingh1992@gmail.com  
 
Source of Monetary or Material Support  
Dr Sarvapalli Radhakrishnan Ayurveda University Jodhpur Rajasthan 
 
Primary Sponsor  
Name  DrSarvepalli Radhakrishnan Rajasthan Ayurved University Jodhpur 
Address  Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur-342037 
Type of Sponsor  Government 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 SANGEETA SINGH MD SHOLAR  P.G. Department of Kriya Sharira, University College of Ayurveda,  Dr.Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur-342037
Jodhpur
RAJASTHAN 
6375900945

drsangeetasingh1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: OJAKSHAYAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  “AUSHADHI PANCHAMRITA YOG” IN OJAKSHAYA  30 clinically Diagnosed Patients of Ojakshya will be randomly selected from OPD & IPD of Dr. S. R. Rajasthan Ayurveda University and Hospital, Jodhpur. “AUSHADHI PANCHAMRITA YOG” 5gms churna added with 2 TSP(10ml) of cows ghrita and 100ml of lukewarm cow milk twice a day will be given for 60 days  
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients full filling the classic signs and symptoms of Ojakshaya will be selected.
2.16-60 age group patients will be taken.
3.Patients of either gender will be taken to study.
 
 
ExclusionCriteria 
Details  1. Individuals below 16 years and over 60 years of age.
2. Patients with any chronic systemic disorders, such as –Madhumeha, Rajaksma, Atisara, Pandu etc.
3. Patient taking any other medication in the duration of study.
4. Pregnant lady and lactating mothers.
CRITERIA FOR WITHDRAWAL: -
1. During the course of trial, if any serious conditions or any serious adverse events which requires urgent treatment.
2. Patients himself wants to withdraw from the clinical trial.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN SUBJECTIVE PARAMETER I.E. SIGNS and SYMPTOMPS OF OJAKSHAYA
1.VIBHETI 2.DURBALOABHIKSHANAM 3.ABHIKSNAM DHYAYATI 4.VYATHITA INDRIYA 5.DUSCHHAYA 6.DURMANA 7.RUKSHA 8.KSAMA 9.MURCHHA 10.MANSAKSHYA 11.MOHA 12.AGYANA
13.PRALAPA
14.MRITYU
 
2 MONTHS(60 DAYS) 
 
Secondary Outcome  
Outcome  TimePoints 
IMPROVEMENT IN OBJECTIVE PARAMETER
1.Complete blood count (CBC)
2.ESR
3.Treadmill Test (TMT)
4.Weight measurement.
 
2 MONTHS(60 DAYS) 
 
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 2 
Date of First Enrollment (India)   15/02/2021 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Ayurveda the age-old science of life has contributed as a major system in maintain and fulfilling the health-related needs of human society. This science has witnessed drastic changes in environments, lifestyle and so on. This had been possible because of strong, universal, unchanged principles of Ayurveda. The epitome of Ayurveda science and utility is firmly standing on fundamental principles of Ayurveda Ojas literally means “vigor”. The Ojas is one of the tools for the achievement of this aim. Acharaya Sushruta describes Ojas as the Paramateja of the Saptadhatus and as the Bala or biological strength of an individual. Ojas act as resistance to Roga which prevents abnormalities in body and acts as protection against various antigens & foreign bodies. It is the quite essential for our life, energy and exists on a subtle level in the body. Disease strikes at the location where there is derangement of Ojas. The diseases such as AIDS, Diabetes, Pandu, Rajaykshma, Ghrahani etc, can manifest features of decreasing immunity or rather Ojakshaya. Vyaadhiksamatva, literally means "resistance (Ksamatva) against disease (Vyadhi).

Ayurveda also mentioned a number of methods to encourage Ojas & Vyadhikshamtva. Factors which contribute for Vyadhikashamatva are normal Dosa, equilibrium state of Dhatu, normal Agni, and patency of Srotasa etc. Protection of health and maintenance of Arogyata is the main aim of Ayurveda. The Physical and mental resistance to disease is of enormous significance to all living beings; it regulates both, prevention against and rapid recovery from diseases. Ojas is located in Haridya (heart) & infiltrates all over the body.

Acharya Charaka describe Ojas Kshaya symptoms like as Vibheti (Person suffer from fear complex), Durbalo Abhikshanam (Physical and mental debility), Vyathita indriya (Feel discomfort in the sense organ), Duschhaya (Developed impaired), Durmana (Bad mentation’s), Ruksha (Dryness), Ksama (Emaciation of the body). Acharyas are describes drugs in various Ayurvedic text for Ojaskshaya like Aushadhi Panchamrita yog.

AIMS AND OBJECTIVES: -

                      1. To Study the Physiology of Ojas along with its function and the references available in classical ayurvedic texts

                        2. Detail study about ojakshaya as mentioned in ayurvedic texts.

                        3. To evaluate the efficacy of Aushadhi Panchamrita Yog in ojakshaya.

SIGNIFICANCE OF STUDY: -

Due to Ativyayama, Anashana, Chinta, Pramitashana, Vata-atapsevana, Bhaya, Shoka, Rukshapaan, Prajagarn, Kala, Abhighata, Ativyavaya etc. there are increased incidence of Ojakshaya in practice and other systems fail to find a satisfactory solution for it. Therefore, it is necessary to find a solution for it through Ayurveda.         An attempt is made to clinically evaluate the efficacy of  Aushadhi  Panchamrita Yog in the treatment of Ojakshaya.

 
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