Ayurveda treatment protocol in the management of Artavadushti W.S.R. to non-obese PCOS
Scientific Title of Study
EEfficacy of oral administration of Erandabhrushta Haritaki Choorna, Kumari Arka and Shatapushpa Taila Matrabasti along with lifestyle modification in the management of Artavadushti W.S.R. to non- obese polycystic ovarian syndrome: A randomized placebo-controlled 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
Lalita Parashar
Designation
M.S. Scholar
Affiliation
Institute of Teaching and Research in Ayurveda, INI, Jamnagar, Gujarat
Address
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, 361008
Jamnagar GUJARAT 361008 India
Phone
7024810375
Fax
Email
lalitaparashar103@gmail.com
Details of Contact Person Scientific Query
Name
Dr Shilpa B Donga
Designation
Professor [HOD]
Affiliation
Institute of Teaching and Research in Ayurveda, INI, Jamnagar, Gujarat
Address
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, 361008
Jamnagar GUJARAT 361008 India
Phone
9825646796
Fax
Email
drshilpadonga@yahoo.com
Details of Contact Person Public Query
Name
Dr Shilpa B Donga
Designation
Professor [HOD]
Affiliation
Institute of Teaching and Research in Ayurveda, INI, Jamnagar, Gujarat
Address
Department of Prasuti Tantra Evum Stree Roga, 5th floor academic building, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, 361008
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, Gujarat, India, 361008
Primary Sponsor
Name
Institute of Teaching and Research in Ayurveda
Address
Institute of Teaching and Research in Ayurveda, Opp City B division Police station, Gurudwara road, Jamnagar, Gujarat, India, 361008
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 LALITA PARASHAR
PG Hospital, OPD no. 06, 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, Gujarat, 361008 Jamnagar GUJARAT
07024810375
lalitaparashar103@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
(Procedure Reference: Sharangdhara Samhita Madhyama Khanda for Sneha Kalpana., Procedure details: Matra basti 60 ml per rectal, after light diet, local Abhyanga and Swedana at Kati, Prushtha and Adhodara Pradesha,once a day in morning for 7 days after cessation of menses for 2 consecutive menstrual cycles) (1) Medicine Name: Shatapushpa, Reference: Kashyap Samhita kalp stana satpushpa satavari kalp adahyaya-5-13, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
Jagrana ¬- waking up early morning (6:00AM-7:00PM)
Malatyaga - excreting faeces
Vyayama - Light exercise including Suryanamaskar, Padmasana, Kapalbhati, Anuloma-Viloma Pranayama according to individual’s capacity (as per Charaka Samhita Vyayam Lakshana ) except during menses.
Snana – taking bath with clean water
Anna Grahana- Eat freshly prepared food and only when hungry.
Sushayya shayana – sleeping on the well-cushioned mattress.
Sedentary life style, excessive & day time sleeping, ratrijagarana, vegavidharana, wearing tight cloths, mental stress, worries, anxiousness.
Deaddiction – Smoking, alcohol, pan masala, tobacco, bidi, cigarettes, excessive use of tea should be stopped.
Do’s Don’ts
Food to be included: Rice, chapati, poha, idli, dal, green leafy vegetables, seasonal vegetables, soups, local fruits, old wheat, Yava, Mudaga, Masura, Aadhaki, Lauki, Turai, Karela, Patola, cow milk, Dadima, Amlaki, Draksha, Purana guda, Takra, Madhu, Shunti siddha jala. Food to be excluded: Cold drinks, packaged juices, chips, chocolates, toffee, pastries, patties, pani poori, maggi, ready to use soups, pizza, burgers, fries, samosa, kachori, bread and pasta, namkeens, tea, coffee, oil seeds, milk curd, paneer, eggs, fish, and meat.
5
Intervention Arm
Lifestyle
-
-
Dinacarya: Jagrana ¬- waking up early morning (6:00AM-7:00PM)
Malatyaga - excreting faeces
Vyayama - Light exercise including Suryanamaskar, Padmasana, Kapalbhati, Anuloma-Viloma Pranayama according to individual’s capacity (as per Charaka Samhita Vyayam Lakshana ) except during menses.
Snana – taking bath with clean water
Anna Grahana- Eat freshly prepared food and only when hungry.
Sushayya shayana – sleeping on the well-cushioned mattress.
Sedentary life style, excessive & day time sleeping, ratrijagarana, vegavidharana, wearing tight cloths, mental stress, worries, anxiousness.
Deaddiction – Smoking, alcohol, pan masala, tobacco, bidi, cigarettes, excessive use of tea should be stopped.
, Ritucarya: -, Acara Rasayana:-, Other:for 2 months, Pathya/Apathya:yes, Pathya:Food to be included: Rice, chapati, poha, idli, dal, green leafy vegetables, seasonal vegetables, soups, local fruits, old wheat, Yava, Mudaga, Masura, Aadhaki, Lauki, Turai, Karela, Patola, cow milk, Dadima, Amlaki, Draksha, Purana guda, Takra, Madhu, Shunti siddha jala., Apathya:Food to be excluded: Cold drinks, packaged juices, chips, chocolates, toffee, pastries, patties, pani poori, maggi, ready to use soups, pizza, burgers, fries, samosa, kachori, bread and pasta, namkeens, tea, coffee, oil seeds, milk curd, paneer, eggs, fish, and meat.
6
Comparator Arm (Non Ayurveda)
-
Placebo control
1 Capsule 500mg, BD, Oral, Half an hour after meal with normal water for 2 months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
Both married /unmarried patients.
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
Patients suffering from chronic pelvic diseases like (Endometriosis, Pelvic Inflammatory Disease, Uterine Fibroid, Menorrhagia, extra), Organic lesions of reproductive tract like Tuberculosis, Carcinoma and congenital deformities and Sexually Transmitted Diseases, Patients with history of cardiac diseases, uncontrolled hypertension (Systolic Blood Pressure above 160 & Diastolic above 100mmhg), uncontrolled Diabetes Mellitus (Fasting Blood Sugar- above the range of 160 mg/dl).
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Case Record Numbers
Blinding/Masking
Participant Blinded
Primary Outcome
Outcome
TimePoints
It is expected that trial drugs will help in the reduction of ovarian volume and induce ovulation.
It is expected that trial drugs will help in the reduction of ovarian volume and induce ovulation at 8 weeks
Secondary Outcome
Outcome
TimePoints
Regulation of menstrual pattern and reduction in hyperandrogenism (clinical/biochemical), improvement of the general health and QOL.
60 days
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 3
Date of First Enrollment (India)
23/03/2025
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
Purpose of the research: 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. Non-obese PCOS is very challenging health issue in present era; non-obese women with PCOS are often undiagnosed for many years. However, many of these modalities were found to be not suitable for the non- obese PCOS. Much contradictory research was found regarding non-obese patients with PCOS in modern science. Moreover, it may fail in prevent the long term consequences of non-obese PCOS. This study will be aiming at early diagnosis and management of non- obese PCOS Information on the Trial procedure and Drug: Here in Group A- Erandabhrushta Haritaki Choorna , Kumari Arka and Shatapushpa Taila Matrabasti along with lifestyle modification. In Group B- Placebo capsule with lifestyle modification. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A. Description of the Process: In present study, participants who will be clinically diagnosed and confirmed cases of Artavadushti w.s.r. to non- obese Polycystic Ovarian Syndrome enlisted in inclusion criteria will be enrolled. All patients will be divided into two groups by computer generated randomisation technique, having minimum of 15 patients in one group. Group A will be given with Erandabhrushta Haritaki Choorna 3gm HS with water orally for 2 months, Kumari Arka 20ml with equal quantity of water BD after meal orally and Shatapushpa Taila Matrabasti 60ml after light diet for 7 days to 2 consecutive menstrual cycles along with lifestyle modification. And Group B will be given with Placebo capsule 500mg BD after meal orally for 2 months with lifestyle modification. Follow-up: Patients will be advised to visit the hospital every 2 weeks during the treatment period (2 months). Follow up will be done for every 2 weeks after the completion of treatment to assess the status of the patient for 1 month. Side Effects: We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects. Results: The efficacy of the therapy will be assessed on the basis of subjective and objective criteria. Benefits: Project will help us to resolve the research question. There may not be any benefit for the society at this stage of the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Artavadushti w.s.r. to non- obese Polycystic Ovarian Syndrome. Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate statistical tests will be applied to compare the effect.