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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Thu, 30 Sep 2021 12:17:01 GMT) 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 A Randomized Control Open Label Clinical Trial On The Efficacy Of Shatapushpa Churna And Study Madhutailika Basti In Nashtartava w.s.r. To Polycystic Ovarian Syndrome Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Shalvi Sharma Trial Coordinator (multi-center study) 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 [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr K Bharathi Query) 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 [email protected] Details Contact Details Contact Person (Public Query) 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 page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 8988071274 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > National Institute of Ayurveda, Madhav Vilas Palace, Amer Road, Jaipur, Rajsthan, 302002 Primary Sponsor Primary Sponsor Details 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 Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Shalvi Sharma National institute of Department of Prasuti 8988071274 Ayurveda Tantra evam Stri Roga National Institute of [email protected] Ayurveda Madhav Villas Palace Jorawar Singh Gate Amer road Jaipur 302002 Jaipur RAJASTHAN Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? INSTITUTIONAL Approved 28/05/2019 No ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA JAIPUR Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Follicular cyst of ovary Intervention / Type Name Details Comparator Agent 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 page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in 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 Inclusion Criteria Age From 18.00 Year(s) Age To 40.00 Year(s) Gender Female Details Patients willing to give voluntary informed consent.<br/> Both married and unmarried patients.<br/> ASRM/ESHRE (Rotterdam) Criteria,2013- Affected individuals must have two out of three criteria<br/> 1. Oligo and /or anovulation<br/> 2. Hyperandrogenism (clinical and /or biochemical).<br/> 3. Polycystic ovaries(Confirmed on USG). Exclusion Criteria Exclusion Criteria Details Patients not willing to give voluntary informed consent. Women of age 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 Computer generated randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints Changes in features of oligomenorrhoea 3 months /anovulation. 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 13/07/2020 Enrollment (India) Date of First No Date Specified page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Enrollment (Global) Estimated Duration of Years=1 Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NIL 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. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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