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CTRI Number  CTRI/2024/12/078172 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   AN OBSERVATIONAL STUDY TO FIND OUT THE ROLE OF IMPROPER RASA DHATU FORMATION IN THE OCCURRENCE OF LIFESTYLE DISORDERS BY STUDYING ONE OF THE DISEASE THAT IS BY STUDYING THE PATIENTS OF PCOD 
Scientific Title of Study   An Observational Study to evaluate the role of Rasadhatu Dushti in Lifestyle disorders wsr to PCOD 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pratiksha Paitod 
Designation  BAMS MD Scholar  
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 
Address  Department of Kriya Sharir Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India
Shri Narayan Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH
492010
India 
Phone  8275393148  
Fax    
Email  paitodpratiksha06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinay Bhardwaj  
Designation  Reader 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 
Address  Department of Kriya Sharir Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India

Raipur
CHHATTISGARH
492010
India 
Phone  9896591482  
Fax    
Email  vinaybhardwaj2610@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Vinay Bhardwaj  
Designation  Reader 
Affiliation  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 
Address  Department of Kriya Sharir Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India

Raipur
CHHATTISGARH
492010
India 
Phone  9896591482  
Fax    
Email  vinaybhardwaj2610@gmail.com  
 
Source of Monetary or Material Support  
Department of Kriya Sharir Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India 
 
Primary Sponsor  
Name  Shri Narayan Prasad Awasthi Government Ayurved College  
Address  Shri Narayan Prasad Awasthi Government Ayurved College GE Road Raipur Chhattisgarh 492010 India India  
Type of Sponsor  Other [Government Ayurved 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 Pratiksha Paitod  Shri khudadad Dungaji Government Ayurved College and Hospital, Raipur Chhattisgarh 492010  Prasuti tantra and Stri-roga OPD number 16 Raipur Chhattisgarh 492010
Raipur
CHHATTISGARH 
8275393148

paitodpratiksha06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of the Principal Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Diagnosed Patients of PCOD
2. Female Patients of age group 18-40 years
3. Selection of Patients irrespective of religion, socioeconomic status and marital status
4. Patient who are willing to participate in the study and agrees to sign consent form  
 
ExclusionCriteria 
Details  1. Female with menopausal syndrome
2. Pregnant and Lactating mothers
3. Patients with other functional and structural pathology of reproductive system like fibroid carcinoma polyp and other new growth (benign/malignant) or patient having malignancies in any system.
4. Patient with congenital anomalies of reproductive system.
5. Patient suffering from endocrinal disorders.
6. Patient suffering from severe systemic infections and tuberculosis.
7. Patient who are not willing to participate in the study and does not agree to sign consent form. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Significant role played by Rasa dhatu dushti in the manifestation of PCOD will be established
There will be strong association between Rasa dhatu dushti and PCOD on assessment scale. 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
There will be strong association between Rasa dhatu dushti and PCOD on assessment scale.  1 year 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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   N/A 
Date of First Enrollment (India)   01/01/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Ayurveda is a holistic science which primarily aims at maintaining health of a person1 .Ayurveda 
have stated many principles including dincharya (rules regarding daily routine), ritucharya (rules to be 
followed in every season), sadavritta (rules regarding basic ethics), all these, concludes a good healthy 
life.
Day by day this practice has been deteriorating. Excessive sugary intake, lack of exercise and 
physical activities, sedentary lifestyle leads to the disturbance of normal circadian rhythm and hence 
making it an impactful cause of many diseases. These group of diseases are termed as lifestyle disorders.
One such common disease affecting females is PCOD (polycystic ovarian disease), availing 
about 8-13% of total reproductive female age group population as stated by WHO. It is characterised 
by irregular menstrual cycles, oligomenorrhea or hypomenorrhea, hirsutism, weight gain, infertility, 
hair fall, acanthosis and other symptoms of androgen excess. Obesity leads to Insulin resistance and LH 
resistance in the body which further dismiss rupture of graffian follicle and hence immature follicles 
rise in ovary which enhance the release of excessive estrogen. This excessive estrogen is then converted 
into androgens in peripheral fat cells thus concluding the androgenic picture of PCOD. 
In Ayurveda PCOD can be categorised under Artava vaha strotas vikar. Artava or Raja is 
mentioned as the upadatu of Rasa Dhatu. Rasa dhatu is the foremost dhatu formed from aahaar rasa
and contain all the nutrients which are required for the development of remaining dhatus of the body. 
Over a period of one month, Rasa gets matured and processed, this is then converted into shukra in men 
and artava (menstrual blood, ovum) in females.Consequently, it takes a full month for the proper 
development of artava during the monthly menstrual cycle. 
PCOD (polycystic ovarian disease) has been a global issue and exhibit symptoms of disturbed menstrual cycle. Ayurveda implies rasa dhatu as the important factor governing ritucharya or menstrual cycle.
So, based upon current scenario, this study focuses upon governing one of the important factor 
that is Rasa dhatu, factors responsible for its vitiation and its effect in terms of PCOD 
                      PCOD (polycystic ovarian disease) has become the common disorder among the females of
reproductive age group contributing about 8-13%. In India it accounts for 10% of total reproductive age
group females4
. Its most common adverse effect on the society is infertility leading to population
imbalance and hence affecting working man power. There is no etiology assessed for this disease till
now. It has been stated as the hormonal disorder but there is no such evidence stating the reason behind
these disturbed hormonal levels.
Hence, there is a fair chance to study the etiology of PCOD by assessing the important factor,
Rasa dhatu, as artaav is the upadhatu of rasa dhatu and it has to be dependent on the status of rasa
dhatu. Hence, if we find out any link between the occurrence of PCOD with Rasa dhatu dushti then we
can try to manage PCOD by means of Rasa dhatu dushti correction with the help of Aahaar, Vihaar,
bheshaj and nidanparivarjana.
The main of this study is the prevention of the disease. Nidanaparivarjan plays the key role and
hence establishment of this link will commence the utmost need to adapt the basic principles of
Ayurveda regarding diet(aahaar), daily routine, rules to be adopted during menstrual cycle (rajaswala
paricharya) especially during puberty period.
Hence, there is a need to evaluate the link between the disease (PCOD) and Rasa dhatu dushti.
Also, this study can act as the basic research for further study regarding the management of disease, its
better prognosis and ultimately prevention of the disease.
Keeping all these in mind, the need for present research work is felt.
 
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