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CTRI Number  CTRI/2025/08/092912 [Registered on: 12/08/2025] Trial Registered Prospectively
Last Modified On: 27/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Evaluation of Nishaamalki and Bhadrasana for PCOD Management 
Scientific Title of Study   A Clinical Comparative Study Of Evaluate The Efficacy Of Nishaamalki And Bhadrasana In Management Of 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  Dr Priyanka Sharma 
Designation  M.D. Schlor 
Affiliation  Sriganganagar College Of Ayurvedic Science And Hospital Srigangnagar 
Address  room no 111 Second Floor Swasthwratt Department Sriganganagar College Of Ayurvedic Science And Hospital Srigangnagar
Second Floor Swasthwratt Department Sriganganagar College Of Ayurvedic Science And Hospital Srigangnagar
Ganganagar
RAJASTHAN
335001
India 
Phone  09460077993  
Fax    
Email  priyankadr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrArchna 
Designation  Associate Professor 
Affiliation  Sriganganagar College Of Ayurvedic Science And Hospital Srigangnagar 
Address  Room no 122 Second Floor Swasthwratt Department Sriganganagar College Of Ayurvedic Science And Hospital Srigangnagar

Ganganagar
RAJASTHAN
335001
India 
Phone  7014755171  
Fax    
Email  Ayurarchna@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrArchna 
Designation  Associate Professor 
Affiliation  Sriganganagar College Of Ayurvedic Science And Hospital Srigangnagar 
Address  Room no 122 Second Floor Swasthwratt Department Sriganganagar College Of Ayurvedic Science And Hospital Srigangnagar

Ganganagar
RAJASTHAN
335001
India 
Phone  7014755171  
Fax    
Email  Ayurarchna@gmail.com  
 
Source of Monetary or Material Support  
Sri Ganganagar College of Ayurvedic science and hospital(A Constituent College of Tantia University) P.G. DEPARTMENT OF SWASTHVRITTA SRIGANGANAGAR pin 335001 RAJASTHAN India 
 
Primary Sponsor  
Name  Sri Ganganagar College of Ayurvedic science and hospital  
Address  Second Floor Swasthwratt Department Sriganganagar College Of Ayurvedic Science And Hospital  
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 Archana Rao  Sriganganagar College of Ayurvedic Science And Hospital Sriganganagar   2nd Floor Swasthvritta Department Sriganganagar College Of Ayurvedic Science And Hospital
Ganganagar
RAJASTHAN 
7014594612

Ayurarchna@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Tantia University ,Sri Ganganagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: PCOD,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmLifestyle--Dinacarya: Na, Ritucarya: Na, Acara Rasayana:Na, Other:Yoga - Bhadrasana, Pathya/Apathya:no, Pathya:, Apathya:
2Intervention ArmDrugClassical(1) Medicine Name: Nishaamlaki churna, Reference: Chraka chikitsa 14/6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Warm water), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Month(s)
Age To  40.00 Year(s)
Gender  Female 
Details  All Subjects With Visible Signs And Symptoms Of PCOD Between The Age Of 20-40Years Of Age 
 
ExclusionCriteria 
Details  Patients With Underlying Morbid/Mortal Diseases
Patients With Other Chronic Co-Morbidities 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Duration of bleeding ,irregular Menstruation amount(quantity) of Blood ,Pain During Menstrual Period  30th Days From Base line in each arm  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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/ Phase 3 
Date of First Enrollment (India)   23/08/2025 
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="0"
Days="30" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Poly Cystic Ovarian Disease (PCOD) is a complex disorder affecting 5-15% women in their
reproductive age and related to ovarian dysfunction  characterized by menstrual irregularities
hyperandrogonism obesity  and infertility. Polycystic Ovary Syndrome (PCOS) and Polycystic
Ovary Disorder (PCOD) are terms often used interchangeably  but they have subtle differences.
PCOD stands for Polycystic Ovary Disorder  and it is primarily a term used in India and some
other countries  while PCOS (Polycystic Ovary Syndrome) is more commonly used in the West.
However  they both refer to the same medical condition. PCOD is a hormonal disorder that
affects women of reproductive age typically starting from their teenage years. It is characterized
by various symptoms  including irregular menstrual periods  excess androgen levels and multiple
small cysts on the ovaries. The exact cause of PCOS is not fully understood  but it likely involves
a combination of genetic and environmental factors. Insulin resistance  where the body s cells do
not respond properly to insulin  is often seen in women with PCOS.
Common symptoms of PCOS:
Irregular Menstrual Periods:     Women with PCOS often have irregular menstrual cycles which
may manifest as infrequent periods  prolonged periods or unpredictable bleeding patterns.
Excess Androgen Levels:    Elevated levels of androgens (male hormones) such as testosterone can
lead to symptoms like acne oily skin  and excessive facial or body hair growth (hirsutism). Some
women may also experience male-pattern baldness or hair thinning on the scalp.
Polycystic Ovaries:    Many women with PCOS have enlarged ovaries with multiple small cysts which can be detected through ultrasound imaging. However, not all women with PCOS willhave cysts on their ovaries. Weight Gain or Difficulty Losing Weight: PCOS is often associated with weight gain particularly around the abdomen. Many women with PCOS struggle to lose weight or may find itdifficult to maintain a healthy weight.
Insulin Resistance:    Insulin resistance, where the body s cells do not respond effectively to insulin
is common in women with PCOS. This can lead to high insulin levels in the blood which may
increase the risk of developing type 2 diabetes
Infertility:   PCOS is a leading cause of infertility in women due to irregular ovulation or lack of
ovulation. Women with PCOS may have difficulty conceiving or may require medical
intervention to achieve pregnancy.
Pelvic Pain:   Some women with PCOS may experience pelvic pain which can range from mild
discomfort to severe cramping. This pain may be associated with ovarian cysts or other
reproductive system issues.
Fatigue:      Chronic fatigue or low energy levels are common among women with PCOS  possibly
due to hormonal imbalances  disrupted sleep patterns  or other underlying factors.
Mood Changes:     PCOS can affect mood and emotional well-being leading to symptoms like
Depression   anxiety  irritability  or mood swings.
Artava Kshaya  is a term from Ayurveda  an ancient system of medicine that originated in
India. In Ayurveda  Artava refers to the menstrual blood  and Kshaya  means a decrease or
depletion. Therefore  Artava Kshaya  translates to a decrease or depletion of menstrual blood.
In Ayurvedic terms Artava Kshaya is considered a disorder related to the female reproductive
system. It indicates an imbalance or dysfunction in the menstrual cycle  resulting in scanty or
decreased menstrual flow. This condition can be caused by various factors  including hormonal
imbalances  stress  poor diet  lack of exercise  or underlying health conditions.
Need of Study:
PCOD is a leading cause of female reproductive and general heath issues in the current times and
thus requires a keen outlook towards its management as not much substantial productive
management protocols exist in synergistic approach towards the same. Thus, the current study
has been planned to assess the efficacy of Nishaamlki and Bhadrasana as a synertic approach.
Review of Literature:
Aim & Objectives:
1. To assess the efficacy of Nishaamalki in management of PCOD.
2. To assess the efficacy of Bhadrasana in management of PCOD.
3. To compare the Efficacy of Nishaamalki and Bhadrasana in management of PCODHypothesis:
Null Hypothesis: There is no significant difference in the efficacy Nishaamlaki,
Bhadrasana & combination of Nishaamlaki and Bhaadrasana in the management of
PCOD.
Research Hypothesis: There is significant difference in the efficacy of Nishaamlaki,
Bhadrasana & combination of Nishaamlaki and Bhaadrasana in the management of
PCOD







 
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