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
|
|
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
|
|
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 “vigorâ€. 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. |