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CTRI Number  CTRI/2020/07/026410 [Registered on: 07/07/2020] Trial Registered Prospectively
Last Modified On: 06/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Study To Assess The Efficacy of Ayurvedic Formulations In PCOS 
Scientific Title of Study   A Randomized Control Open Label Clinical Trial On The Efficacy Of Shatapushpa Churna And Madhutailika Basti In Nashtartava w.s.r. To Polycystic Ovarian Syndrome 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shalvi Sharma 
Designation  M.S. Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Prasuti Tantra evam Stri Roga National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road

Jaipur
RAJASTHAN
302020
India 
Phone  8988071274  
Fax    
Email  shalvi0699@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K Bharathi 
Designation  Professor and H.O.D. 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Prasuti Tantra evam Stri Roga National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road

Jaipur
RAJASTHAN
302020
India 
Phone  9982678508  
Fax    
Email  baruhunt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shalvi Sharma 
Designation  M.S. Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Prasuti Tantra evam Stri Roga National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road

Jaipur
RAJASTHAN
302020
India 
Phone  8988071274  
Fax    
Email  shalvi0699@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Madhav Vilas Palace, Amer Road, Jaipur, Rajsthan, 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  Department of Prasuti Tantra evam Stri Roga National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road Jaipur 302002 
Type of Sponsor  Research institution and hospital 
 
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 Shalvi Sharma  National institute of Ayurveda  Department of Prasuti Tantra evam Stri Roga National Institute of Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road Jaipur 302002
Jaipur
RAJASTHAN 
8988071274

shalvi0699@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N830||Follicular cyst of ovary,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A Shatapushpa Churna  Shatapushpa Churna 6gm orally with Ghrita twice a day for a period of 90 days or 3 consecutive cycles. 
Comparator Agent  Group B Madhutailika Basti  Madhutailika Basti 400mL per rectal empty stomach For irregular cycles- For 7 days (after initial screening), then there is a waiting period of fifteen days, during which the patient may get her periods. The next seven days of medicine is started seven days prior to the expected date of next menstruation, in case she does not get her periods, medicine again started for seven days, after the waiting period, this follows for three cycles of medicine administration. For regular cycles- Seven days prior to the expected date of menstruation for three consecutive cycles.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients willing to give voluntary informed consent.
Both married and unmarried patients.
ASRM/ESHRE (Rotterdam) Criteria,2013- Affected individuals must have two out of three criteria
1. Oligo and /or anovulation
2. Hyperandrogenism (clinical and /or biochemical).
3. Polycystic ovaries(Confirmed on USG). 
 
ExclusionCriteria 
Details  Patients not willing to give voluntary informed consent.
Women of age <18years and >40years.
Patients with chronic systemic illness (Congestive cardiac failure, Hypertension, cirrhosis of liver, chronic renal disease, diabetes mellitus, Tuberculosis etc.).
Patients using oral contraceptive pills.
Patients with any organic reproductive system abnormalities (Excluded clinically and radiologically), pelvic inflammatory disease, hydrosalpinx, endometriosis, adenomyosis, fibroid uterus, carcinoma of reproductive organ.
Any type of malignancy.
Patients with positive Sexually transmitted diseases (STDs), Human Immunodeficiency Virus HIV, Hepatitis B Surface Antigen(HbsAg).
Patients suffering from adrenal hyperplasia, severe insulin resistance, androgen secreting neoplasm, thyroid abnormalities, Cushing’s syndrome. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in features of oligomenorrhoea /anovulation.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in PCOS features (i.e. acne, hirsutism).  3 months 
 
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)   13/07/2020 
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="1"
Months="6"
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)?  

Brief Summary   Polycystic ovarian syndrome (PCOS) is a most prevalent endocrinopathy. It is common metabolic-endocrine-reproductive disorder. It leads to menstrual irregularities ranging from amenorrhea to dysfunctional uterine bleeding, hirsutism, acne, anovulation and sub fertility. Incidence of this disease is increasing now a days because of sedentary lifestyles, pollution and excessive intake of junk food. Diagnosis of PCOS is based on the presence of any two of the three criteria (ASRM/ESHRE, 2003) – (1) Oligo and or anovulation (2) Hyperandrogenism (clinical and /or biochemical) (3) Polycystic ovaries. 
As per Ayurveda this condition is not explained as a single disease entity, but given under the headings Yonivyapada (genital disorders), Artava Dushti (menstrual disorders), Pushpaghni Jataharini etc. Ayurvedic management is beneficial in controlling the three aggravated Doshas & brings balance & strength to the reproductive system& it helps to regulate Artava Dhatu. In view of this, Shatapushpa Churna and Madhutailika Basti are selected as trial drugs so as to provide an easy and cost effective therapeutic measure for PCOS. 30 patients suffering from Nashtartava (PCOS) from OPD & IPD National Institute of Ayurveda, Jaipur will be selected according to the inclusion criteria , irrespective of religion, occupation and socio-economic status. Patients will be randomly divided into two groups. In group A  Shatapushpa Churna orally with Ghrita and group B Madhutailika Basti per rectum.
Shatapushpa Churna will be given 6gm orally with Ghrita twice a day for a period of 90 days or 3 consecutive cycles.
Madhutailika Basti 400mL per rectum empty stomach as following-
For irregular cycles- For 7days (after initial screening), then there is a waiting period of fifteen days, during which the patient may get her periods. The next seven days of medicine is started seven days prior to the expected date of next menstruation, in case she does not get her periods, medicine again started for seven days, after the waiting period, this follows for three cycles of medicine administration.
For regular cycles- Seven days prior to the expected date of menstruation for three consecutive cycles.
During trial, follow up will be done after completion of one menstrual cycle. After completion of the trial, case will be followed after one month. Assessment will be done on the basis of objective and subjective parameter before treatment, after treatment, and during last follow up. Appropriate statistical test will be applied.
 
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