| CTRI Number |
CTRI/2024/05/066674 [Registered on: 02/05/2024] Trial Registered Prospectively |
| Last Modified On: |
01/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurveda treatment protocol in the management of Artavadushti W.S.R. to non-obese PCOS |
|
Scientific Title of Study
|
Efficacy of Nitya Virechana with Naracha Choorna, Sahacharadi Taila Matra Basthi and Shatapushpadi Yoga orally in the management of Artavadushti W.S.R. to non-obese polycystic ovarian syndrome: A Single Arm Open Labelled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arya Shaji |
| Designation |
M.S. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
9961391504 |
| Fax |
|
| Email |
shajiarya084@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpa B Donga |
| Designation |
Professor [I/C HOD] |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shilpa B Donga |
| Designation |
Professor [I/C HOD] |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar
GUJARAT 361008 India |
| Phone |
9825646796 |
| Fax |
|
| Email |
drshilpadonga@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Opp.B-Division Police Station, Gurudwara Road, Jamnagar, Gujarat 361008 |
| 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 Arya Shaji |
PG Hospital, OPD no. 07, Institute of Teaching and Research in Ayurveda, Jamnagar |
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar Jamnagar GUJARAT |
09961391504
shajiarya084@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda (INI), Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Ashtanga Hridaya Chikitsasthana Adhyaya 21, Procedure details: Local Abhyanga and Swedana at Kati, Prushtha and Adhodara Pradesha, Matra Basti) (1) Medicine Name: Sahacharadi Taila, Reference: Ashtanga Hridaya Chikitsasthana Adhyaya 21, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Naracha Choorna, Reference: Sharangdhara Samhita Madhyamakhanda Adhyaya 6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shatapushpadi Yoga, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Both married /unmarried patients in the age group of 18-40 yrs.
Diagnosed cases as per ASRM (American society for reproductive medicine)/ESHRE (European society of human reproduction and embryology) criteria for PCOS.
Patient willing to give written informed consent by themselves
BMI less than or equal to 25 kg/m2
|
|
| ExclusionCriteria |
| Details |
Age group less than 18yrs and more than 40yrs
BMI more than 25 Kg/m2
Patients suffering from chronic Pelvic diseases like (Endometriosis, PID, Uterine Fibroid, Menorrhagia, etc.)
Organic lesions of reproductive tract like Tuberculosis, Carcinoma and congenital deformities and Sexually Transmitted Diseases.
Patients with history of cardiac diseases, uncontrolled hypertension (Systolic BP above 160 & Diastolic above 100mmhg), uncontrolled Diabetes Mellitus (FBS- above the range of 160 mg/dl)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is Expected that trial drugs will help in the reduction of ovarian volume. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is expected that trial drugs will help in the regulation of menstrual pattern and induce ovulation. |
2 months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| 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="6" 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
|
Introduction:
Polycystic Ovarian Syndrome [PCOS] is the most common
endocrine and metabolic disorder in a woman of reproductive age. It is a
multifactorial and polygenic condition. It is heterogenous by nature and can be
defined by a combination of sign and symptoms of androgen excess and ovarian
dysfunction in the absence of other specific diagnosis. It is a complex
syndrome showing the clinical features of an endocrine/metabolic disorder,
including hyperinsulinemia and hyperandrogenism. Clinically it is characterized
by menstrual abnormalities, hirsutism, acne, obesity, insulin resistance and
baldness.
There are two phenotypes of PCOS, obese
and non-obese with different biochemical hormonal and metabolic profiles.
Although a majority of cases with PCOS are obese/overweight, a small but
significant proportion of patients present with normal body mass index or low
BMI (≤25 kg/m2) that makes diagnosis work up and therapeutic approach more
difficult. These cases of PCOS are termed as non-obese PCOS. Causative factor
for non-obese PCOS are stress factor, nutritional factor and genetic factor.
Women with non-obese PCOS may struggle with irregular periods, anxiety,
uncontrolled blood sugar, fertility problems, and other caused by elevated
androgen (testosterone) levels such as excess facial hairs and acne.
Rationale for selection of the
topic:
PCOS is a global health issue for women’s health in current
scenario due to changes in life style, habits and mental stress from menarche
to menopause. Overweight women with PCOS may be diagnosed with their absent or
irregular 3 cycles when they are still in high school. Comparatively, non-obese
PCOS women may not diagnosed until they struggle to conceive.
There are only few research works available on non-obese
PCOS.There is no fixed protocol or interventional drug or procedure to approach
non-obese PCOS patients.
Drugs for the selected study are Naracha Choorna, Sahacharadi
Taila and Shatapushpadi Yoga. Acharya Charaka has said that repeated
elimination of Doshas should be done by Mrudu Virechana drug in
weak patients who have more Doshas. Naracha Choorna helps in Vatanulomana.
Sahacharadi Taila is Vatashamaka and Yonidoshahara due to Ushna-Tikshna
properties. Acharyas have mentioned Rasayana and Doshanusara Chikitsa
in Artvadushti .So, Shatapushpadi Yoga that contains Shatapushpa,Shatavari
and Brahmi has been selected for the same.
Aim: - To evaluate the
efficacy of Nitya Virechana with Naracha Choorna, Sahacharadi Taila Matrabasti and Shatapushpadi Yoga orally in the management of non-obese PCOS.
Objectives:
• To assess the efficacy
of Nitya Virechana with Naracha choorna, Sahacharadi Taila
Matra Basthi and Shatapushpadi Yoga
orally on ovarian morphology.
• To assess the efficacy of Nitya Virechana with
Naracha Choorna orally, Sahacharadi Taila Matra Basthi and Shatapushpadi Yoga orally on menstrual abnormality.
Materials and Methods: Primarily, subjects will be selected
on the basis of symptoms of PCOS. Further, if subjects fulfill the inclusion
criteria and suspected pathologies if any, are ruled out, then appropriate
written informed consent will be taken from the subjects to participate in the
study. The cases will be registered for the clinical trial from O.P.D and I.P.D
of Department of Prasuti Tantra Evam Stree Roga or such cases referred from
other departments of ITRA Jamnagar irrespective of Caste and religion .
Patients will be screened and examined with the help of Rotterdam criteria of
non-obese (BMI ≤25 kg/m2) PCOS based on clinical and USG parameters. Further
assessment will be done according to specially designed proforma.Sample size of
the study will be 20, assigned in a single group.Naracha choorna for Nitya
virechana orally ,Sahacharadi taila Matra Basti in two consecutive
menstrual cycle and Shatapushpadi Yoga orally will be administerd for 2
months.Followup period will be 1 month.
Results and
Discussion: Data generated during the above study will be presented in a systemic
manner and shall be analysed statistically. The important points of the
Conceptual study, Analytical study, Pharmacological study will be discussed.
Side Effects: This drug has no
known unwanted effects. Adverse Drug Reaction if any observed will be reported
to the Pharmacovigilance cell of I.T.R.A., Jamnagar. |