A Comparative Study of Homoeopathic Treatment Versus Integrated Approach of Homoeopathy and Yoga in the Treatment of Menstrual Disorders in Females With Polycystic Ovarian Syndrome.
Phase: NA
Conditions: Menstrual Disorders, Polycystic Ovary Syndrome
Sponsor: Fr Muller Homoeopathic Medical College

   
A comparative study of 
homoeopathic treatment versus 
integrated approach of 
homoeopathy and yoga in the 
treatment of menstrual disorders 
in females with PCOS  
  
  
Document Modified on 20.06.2018  
  
  
A comparative study of homoeopathic treatment versus integrated approach of 
homoeopathy and yoga in the treatment of menstrual disorders in females with PCOS.  
  

  
Title of the study   
  
  
   
   
  
  
MATERIALS AND 
METHODS – study 
design, sample size, 
methodology  
  
A comparative study of homoeopathic treatment versus integrated approach 
of homoeopathy and yoga in the treatment of menstrual disorders in females 
with PCOS.  
  
  
Study design: Interventional Study.  
  
Sample size-Total number of participants is 84. The participants in the study 
will be categorised into two groups. 42 cases of PCOS will be treated with 
homoeopathic treatment and 42cases will be enrolled for homoeopathic 
treatment along with regular yoga therapy. The numbers of these cases are 
based on the availability and frequency of their visits to our OPD.   
  
  
Sample size calculation  
Assuming that the effect size =0.5 at 98% C.I and 90% power, the required 
sample size is 84 cases, 42 in each group.  
Formula used   
  
                   n    =   2(Z α+Zβ)2 p(1-p)  
                                   (p1-p2)  
Z α=1.96 at 95%C.I  
Z β=1.281at 90%power  
  
(p1-p2)  =   0.5(effect size)  
                                 p(1-p)   
2(1.96+1.281)2  
(0.5)2  
 

 
  
21.008  
(0.5)2  
  
84cases  
42+42 in each group  
Methodology-  
All these cases of PCOS will be diagnosed according to Rotterdam 
criteria(Ref- Focus Reproductive health Polycystic ovary syndrome 
AnupdateVolume 41, No.10, October 2012 Pages 752-756) and 
FerrimanGallwey scale for hirsutism (Ref-Ferriman DM, Gallwey JD. 
Clinical assessment of body hair growth in women. J ClinEndocrinol 
1961:21:1440–1447).  
  
    The data will be collected in the enclosed case format. 42 subjects of 
PCOS will be treated with homoeopathic treatment and 42 subjects will be 
enrolled for homoeopathic treatment along with regular yoga therapy trained 
by a professional.  
The subjects will be recruited to receive treatment randomly, based on sealed 
envelope method. Each subject will be followed up for 1 year to assess the 
outcome of the treatment .The follow-up of these cases will be assessed 
symptomatically and by clinical assessment. At the end of the treatment 
reduction in hirsutism will be assessed by Ferriman-Gallwey scale for 
hirsutism and hormonal assay will be done to find out reduction in 
hyperandrogenism . Each case will be evaluated before and after treatment 
as per the study protocol.  
    
     

 

 1.Inclusion criteria includes:  
• 
Female aged 18-36years   
• 
Females diagnosed with PCOS according to Rotterdam criteria.  
• 
Participants willing to adopt a healthy life style and regularly practice yoga (at least 30 minutes for 
  
2.The Exclusion criteria includes:  
• 
Diabetes mellitus, Cushing's disease, hyper-prolactinemia  
• 
Untreated hypo or hyperthyroidism   
• 
Adrenal hyperplasia and adrenal tumour  
• 
Ovarian tumourhyperthecosis  
• 
History of intake of drugs aldactone/metformin or history of oral contraceptive pills (OCP) use or in
interfere with carbohydrate metabolism 4 weeks prior to enrolment  
pregnancy, breast feeding cases with any systemic disease.  
    
  
 Homoeopathic 
n=42  
treatment  
Integrated  
treatment 
 
with homoeopathic 
treatment and yoga therapy 
n=42  
  
  
Population: Females aged between 18-36yrs, visiting the Homoeopathic OPD at Deralakatte, Kankanady an
treatment of menstrual irregularities.  
  
 
 
Females  
with  
PCOS  
fulfilling  
eligibility criteria  
18-36 yrs  
n=84  

 

 
Sampling technique: Simple random sampling.  
  
Feasibility: The study is feasible in terms of availability of patients at our 
OPD settings  
  
  
Duration of study: Total of 3 years. All 84 cases are expected to be registered 
in a span of 1year 6 months. Registration will be followed by treatment of 
1year, with 6 months for analysis and reporting by the end of 3 years.   
  
Types of Intervention  
Patients fulfilling the eligibility criteria, among which 42 will be enrolled for 
homoeopathic treatment, 42 will be enrolled for homoeopathic treatment 
integrated with daily yogic practice .Medicine shall be given in Q, 6C, 30C, 
200C or 1M potency as per the prescribing totality. The medicine will be 
repeated depending on the potency and complaints of the patient in 
accordance with the principles of homoeopathy.  Yoga therapy includes daily 
yogic practice which include –  
1. Physical postures (Asanas - 1 min each):   
      a.   Surya Namaskara (Sun Salutation) for 10 min [5 rounds];        
b.   Prone asanas:   
• 
Cobra Pose (Bhujangasana),   
• 
Locust Pose (Salabhasana),   
• 
Bow Pose (Dhanurasana)  
d. Standing asanas:  
• 
Triangle Pose (Trikonasana),   
• 
Twisted Angle Pose (Parsva -konasana),   
• 
Spread Leg Intense Stretch (Prasaritapadottanasana);   
e. Supine asanas –   
• 
Inverted Pose (ViparitaKarni),   
• 
Shoulder Stand (Sarvangasana),   
• 
Plough Pose (Halasana);   
f. Sitting asanas    
• 
Sitting forward Stretch (Paschimottanasana),   
• 
Fixed angle Pose (Baddha- konasana),   

• 
Garland Pose (Malasana)   

 
 
2. 
Breathing Techniques (Pranayama – 2 min each):   
• 
Sectional Breathing (Vibhagiya- Pranayama),   
• 
Forceful Exhalation (Kapalabhati),   
• 
Right Nostril Breathing (SuryanulomaViloma) 2 min,   
• 
Alternate nostril breathing (Nadishuddhi)   
3. 
Guided relaxation (Savasana) for 10 min   
4. 
OM Meditation (OM Dhyana) for 10 min   
5. 
Group Lecture: Lectures, in the form of cognitive restructuring 
based on the spiritual philosophy underlying yogic concepts, spiritual 
coping strategies  
Assessment of treatment outcome  
Assessment of regularity in menstrual cycle will be based on recording the 
LMP and duration of menstrual cycle on a monthly basis during the patients 
visit to the OPD.  
Assessing the reduction in hyperandrogenism- Based on physical 
examination according to Ferriman Gallwey scale, hormonal assay 
(LH,FSH,Prolactin,Testosterone )before and after treatment.  
  

  
The collected data will be analyzed by frequency, percentage, mean, standard 
deviation, t test and chi-square test.   
  
Null Hypothesis: No significant difference in cases of PCOS treated with 
homoeopathic medicines compared to cases treated with integrated approach 
of homoeopathic treatment and yoga.  
  
Alternate Hypothesis: There may be a significant difference in cases of 
PCOS treated with homoeopathic medicines compared to cases treated with 
integrated approach of homoeopathic treatment and yoga.  
  
Biostatistician  
Mrs Sucharitha Suresh, MSc(Statistics), Assistant Professor, Department of  
Community 
Medicine, 
Fr 
Muller 
Medical 
College, 
Kankanady,Mangaluru575002  
  
  
A comparative study of 
homoeopathic treatment versus 
integrated approach of 
homoeopathy and yoga in the 
treatment of menstrual disorders 
in females with PCOS  
  

Informed Consent  
  
  
Document Modified on 20.06.2018  
  
  
 

 
  
CONSENT  
  
Study title:  A comparative study of homoeopathic treatment versus 
integrated approach of homoeopathy and yoga in the treatment of menstrual 
disorders in females with PCOS.  
Subject Name: _______________  
  
Date of Birth/Age: ____________  
  
Address: ____________________  
  
 
  
______________________  
  
(i)  
I confirm that I have read and understood the 
information sheet for the above study and have had the 
opportunity to ask questions and have received 
satisfactory answers.  
[          ]  
(ii)  
I understand that my participation in the study is 
voluntary and that I am free to withdraw at any time, 
without giving any reason, without my medical care or 
legal rights being affected  
[          ]  
(iii)  I understand that the sponsor of the clinical trial, other 
working on the Sponsor’s behalf, the ethics committee 
and the regulatory authorities will not need my 
permission to look at my health records, both in respect 
of the current study and any further research that may 
be conducted in relation to it, even if I withdraw from 
the trial. I agree to this access. However, I understand 
that my identity willnot be revealed in any information 
released to third parties or published.  
[          ]  
(iv)  I agree not to restrict the use of any data or results that 
arise fromthis study provided such a use is only for 
scientific purpose(s).  
[          ]  
(v)  
I agree to take part in the above study.  
[          ]  
  
Please initial (subject) the boxes provided above.  
   

 
    
All the above has been explained to me in the language I know and I 
understand. I have received a signed copy of the informed consent Form.  
  
________________________________  
  
       Date:   
Signature (or thumb impression) of the  
subject/legally acceptable representative  
  
________________________________     
Signatory's name  
  
______________________________________    
Date:  
Signature of person administering informed consent 
discussion  
  
_____________________________________   Name 
of person administering informed  
consent discussion                                               
_____________________________________     
Signature of impartial witness  
  
______________________________________   
Name of impartial witness  
  
Date: