| CTRI Number |
CTRI/2024/05/067175 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to know the effect of Ayurvedic drugs and diet in the management of Poly cystic ovarian syndrome |
|
Scientific Title of Study
|
A Randomized comparative clinical study to evaluate the efficacy of indigenous drugs and pathya ahara vihara in the management of PCOS. |
| 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 Lavanya Holeyannavar |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi University of Health Science Bangalore Karnataka |
| Address |
OPD NO 08 Prasuti tantra and stree Roga Department,Sanjeevini Ayurveda Medical College and Hospital,Hubli,Karnataka
Dharwad KARNATAKA 580030 India |
| Phone |
9741879207 |
| Fax |
|
| Email |
lavanyaholeyannavar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gourish Asuti |
| Designation |
Professor and HOD |
| Affiliation |
Rajiv Gandhi University of Health Science Bangalore Karnataka |
| Address |
OPD NO 08 Prasuti tantra and stree Roga Department,Sanjeevini Ayurveda Medical College and Hospital,Hubli,Karnataka
Dharwad KARNATAKA 580030 India |
| Phone |
9886669910 |
| Fax |
|
| Email |
drgourish83@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gourish Asuti |
| Designation |
Professor and HOD |
| Affiliation |
Rajiv Gandhi University of Health Science Bangalore Karnataka |
| Address |
OPD NO 08 Prasuti tantra and stree Roga Department,Sanjeevini Ayurveda Medical College and Hospital,Hubli,Karnataka
KARNATAKA 580030 India |
| Phone |
9886669910 |
| Fax |
|
| Email |
drgourish83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjeevini
Ayurveda Medical College and Hospital Hubli Dharwad Karnataka India
580030 |
|
|
Primary Sponsor
|
| Name |
Dr CC Hiremath |
| Address |
Sanjeevini
Ayurveda Medical College and Hospital Hubli Dharwad Karnataka India 580030 |
| Type of Sponsor |
Other [Principal Sanjeevini Ayurvedic Medical college and Hospital Hubli Dharwad Karnataka India 580030] |
|
|
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 Lavanya Holeyannavar |
Sanjeevini Ayurveda Medical College and Hospital,Hubli,Karnataka |
OPD NO 08 Prasuti Tantra and Stree Roga Department Sanjeevini
Ayurveda Medical College and Hospital Hubli Karnataka India Dharwad KARNATAKA |
9741879207
lavanyaholeyannavar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sanjeevini Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: PC NORM, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: MC NORM, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Wheat flour as placebo |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Rotterdam creteria - With following symptoms of PCOS if any two of the following are present
(1) clinical or biochemical hyperandrogenism,
(2) Evidence of oligo-anovulation,
(3) Polycystic appearing-ovarian morphology on ultrasound
(4) Both married and unmarried females |
|
| ExclusionCriteria |
| Details |
1 Patients suffering from Pelvic diseases like Endometriosis, Hydrosalphinx, Fibroid uterus, T.B, Carcinoma and Congenital deformities.
2 Patients having physiological infrequent menstruation.
3 Woman taking Oral Contraceptive Pills.
•Subjects with systemic illness interfering with the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is to prevent the symptoms and to restore menstrual cycle with proper ovulation in women health and to have healthy progeny and to relive the agony of patient with the help of a safe and cost effective medicaments. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
07/06/2024 |
| 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="0" Days="0" |
|
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
|
Polycystic ovary syndrome (PCOS) is a common
hormonal condition that affects women of reproductive age. It usually starts
during adolescence, but symptoms may fluctuate over time. PCOS can cause
hormonal imbalances, irregular periods, excess androgen levels and cysts in the
ovaries. Irregular periods, usually with a lack of ovulation, can make it
difficult
to become pregnant. PCOS is a leading cause of infertility. PCOS
is a chronic condition and cannot be cured. However, some symptoms can be
improved through lifestyle changes, medications and fertility
treatments. PCOS a significant public health problem and is one of the
commonest hormonal disturbances affecting women of reproductive age. The
condition affects an estimated 8–13% of women of reproductive age, and up to
70% of cases are undiagnosed. The prevalence of PCOS is
higher among some ethnicities and these groups of often experience more
complications, in particular related to metabolic problems. The biological and
psychological effects of PCOS, particularly those related to obesity, body
image and infertility, can lead to mental health challenges and social stigma.
In
Ayurveda PCOS can be correlated to some extent with Artava-kshaya or with Pushpaghni jataharani The symptoms of Artava-kshaya is Yathochita-kala-adarshana means Apravrutti of Artava in its Yogya Kala
(it may be delayed or absent), Artava
is Alpa in pramana (scanty bleeding) and Yoni-vedana.
The symptoms of Pushpaghni Jataharani
is Vyartha-Pushpa-darshana (anovular
menstruation), Sthula-Ganda-pradesha (cheeks
are corpulent) and Lomayukta (hirsutism).
In
present era of globalization due to transient change in the life style to a
more of sedentary life style, exercise
over time, lack of physical exercise, stress, high caloric food and indiscriminate
dietary habits leading PCOS A medical
intervention of polycystic ovarian disease and syndrome includes hormonal
therapies which have long term health consequences. There by researchers are
looking for the ayurvedic (Herbal) medicine for the treatment of PCOS in
alternative medicine which do not causes any side effects. The indigenous drugs
namely MC-Norm and PC-Norm which are kapha-vatashamaka, having rochan, deepan,
pachan, anulomaka properties. PCOS is a life style disorder even here is also an another attempt made to
evaluate the effect Placebo – Wheat flour capsule with pathya aahara and vihara
in the management of PCOS. Hence the study has undertaken to evaluate the
effect of in indigenous compound in the
management of PCOS. |