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
|
|
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
|
|
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. |