CTRI/2025/02/080991 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On:
19/02/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
ayurvedic management of Obese PCOS
Scientific Title of Study
Efficacy of Virechana Karma and Lekhana Basti along with Pathadi Yoga Ghanavati and Phalatrikadi Kwatha in ovulation induction in obese polycystic ovarian syndrome: open labelled randomized 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
Nidhi Bipinkumar Patel
Designation
MS Scholar
Affiliation
Institute of Teaching and Research in Ayurveda Jamnagar
Address
Department of Prasutitantra evam Streeroga,Fifth floor, Instuitute building, ITRA Jamnagar, Opp.B.Division police station, Gurudwara road, Jamnagar, Gujarat
Jamnagar GUJARAT 361008 India
Phone
7984834905
Fax
Email
np187186@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sipika Swati
Designation
Assistant Professor
Affiliation
Institute of Teaching and Research in Ayurveda Jamnagar
Address
Department of Prasutitantra evam Streeroga,Fifth floor, Instuitute building, ITRA Jamnagar, Opp.B.Division police station, Gurudwara road, Jamnagar, Gujarat
Jamnagar GUJARAT 361008 India
Phone
9889501569
Fax
Email
drsipika@ayurveduniversity.com
Details of Contact Person Public Query
Name
Dr Sipika Swati
Designation
Assistant Professor
Affiliation
Institute of Teaching and Research in Ayurveda Jamnagar
Address
Department of Prasutitantra evam Streeroga,Fifth floor, Instuitute building, ITRA Jamnagar, Opp.B.Division police station, Gurudwara road, Jamnagar, Gujarat
Jamnagar GUJARAT 361008 India
Phone
9889501569
Fax
Email
drsipika@ayurveduniversity.com
Source of Monetary or Material Support
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat Opp B Divison police station Gurudwara road Jamnagar Gujarat 361008
Primary Sponsor
Name
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat
Address
Department of Prasutitantra evam Streeroga,Fifth floor, Instuitute building, ITRA
Jamnagar, Opp.B.Division police station, Gurudwara road, Jamnagar, Gujarat Pincode 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 Nidhi Patel
Institute of Teaching and Research in Ayurveda Jamnagar Gujarat
O.P.D. No.6, Prasutitantra evam Streeroga, Institute of Teaching and Research in Ayurveda Jamnagar, Opp.B.Division Police Station, Gurudwara Road, Jamnagar 361008 Gujarat Jamnagar GUJARAT
7984834905
np187186@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 Jamnagar Gujarat
(1) Medicine Name: Phalatrikadi kwatha, Reference: Agnivesh. Prameha chikitsa 6/40, Charak Samhita. part II, Chaukhambha Bharti Academy, Varanasi.2011; 240., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -
4
Intervention Arm
Procedure
-
virecana-karma, विरेचन-कर्म
(Procedure Reference: Shree nandkishorsharma, Astangsamgraha of vagbhatta, uttartantra, granthichikitsaadhyay. Cha 34, ver 26. Reprint edition, varanasiChaukhambhaoriantalia, 2015. page no 412, Procedure details: 1. Deepana, Pachana 2 gm with Trikatu Churna 3 times a day with warm water for 5-7 Days
2. Snehapana with Go Ghrita (as per Kostha and Agni) Starting from 30 ml and there after increasing the dose everyday by calculating the time taken for digestion of Sneha until Samayak Snigdha Lakshana obtained for 3-7 Days
3. Abhyanga with Bala Taila (Sida cordifolia Linn) followed by Bashpa Swedana – once a day for 3 Days
4. Abhyanga, Swedana & Virechana Karma with Trivritadi Avaleha – 70 to 100 gm (as per Kostha and Agni) 1 Day
5. Samsarjana Karma Diet (As per Shuddhi) for 3-7 Days
) (1) Medicine Name: Trivrutta avleha, Reference: Prof. K. R. Srikanta Murthy. Ashtanga Hridayam. 5th ed. Varanasi: Chowkamba Krishna das Academy; 2003. Chikitsa sthana, Vata Vyadhi Chikitsa,Chapter 21 ver.69; P 509, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Duration: 1 Days
5
Intervention Arm
Procedure
-
bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म
(Procedure Reference: Sustrutasamhita of susruta, Chikitsa sthana- 38/82, with nibadhasngraha comm.- of sridalhanacharya- edited by YKT Acharya- Varanasichaukambhaorietalia-2007; p 174, Procedure details: 350 ml, once a day, empty stomach for 8 days after cessation of menses
Preparation:
For Niruha Basti, Basti Dravya will be prepared by proper mixing in the order of Saindhav, Madhu, Taila, Kalka, Kashaya and lastly Aavapa. Finally, homogenous mixture will be formed. This mixture will be filtered and used for Lekhana Basti.
Procedure:
Poorva Karma-
Snehana: Abhyanga with Bala Taila at Kati Pradesha (back side) & Adhodara (Lower abdomen) for 10 minutes.
Swedana: Sthanika Nadi Sweda with Ushna Jala as per need.
Pradhana Karma:
After Poorva Karma Patient will be advised to lie down in left lateral position, little quantity of Bala Taila will be applied on patient’s anal area and Basti nozzle. The Basti nozzle will be attached to enema pot containing 350 ml of Lekhana Basti and it will be gently inserted into anal canal with uniform pressure.
Pashchat Karma:
After Pratyagamana of Basti Dravya and evacuation of bowel, patient will be advised to take hot water bath, light diet and proper rest.
) (1) Medicine Name: Lekhana basti, Reference: Sustrutasamhita of susruta, Chikitsa sthana- 38/82, with nibadhasngraha comm.- of sridalhanacharya- edited by YKT Acharya- Varanasichaukambhaorietalia-2007; p 174, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 350(ml), Frequency: od, Duration: 8 Days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
40.00 Year(s)
Gender
Female
Details
Patients with BMI more than 30 kg/m2
Patients with any 3 or more clinical features of PCOD like-
Amenorrhea or Oligomenorrhoea
Anovulation
Infertility (Due to anovulation)
Acne
Hirsutism (Ferryman-Gallwey scale)
Acanthosis nigricans.
Confirmation of Polycystic Ovary along with anovulatory cycles in USG finding.
Patient eligible for Virechana Karma and Lekhana Basti.
ExclusionCriteria
Details
Patient with infectious diseases of reproductive tract like tuberculosis, sexually transmitted diseases.
Patients suffering from Pelvic diseases like Endometriosis, pelvic inflammatory disease, Uterine Fibroid.
Organic lesions of reproductive tract like tuberculosis, carcinoma and congenital deformities.
Patients with history of cardiac diseases, Chronic liver disease, Uncontrolled Diabetes more than 160 mg/dl- fasting blood sugar and Hypertension Systolic blood pressure more than 160 and Diastolic more than 100mmhg, Tuberculosis
Patient with Hepatitis C, Hepatitis B, Hyperprolactinemia, Hypothyroidism.
Patient not eligible for Virechana Karma and Lekhana Basti.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Case Record Numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
It is expected that treatment protocol will help in growth of dominant follicle, ovulation, reduction of ovarian volume as well as menstrual regulation,
Reduction in body weight, Waist hip ratio, Insulin Resistance and Hirsutism
During treatment period of 4 month
Secondary Outcome
Outcome
TimePoints
Treatment protocol will help in conception
During treatment period of 4 month
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)
11/03/2025
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="6" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
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
‘‘EFFICACY OF VIRECHANA KARMA AND LEKHANA BASTI ALONG WITH PATHADI YOGA
GHANAVATI AND PHALATRIKADI KWATHA IN OVULATION INDUCTION IN OBESE POLYCYSTIC
OVARIAN SYNDROME: OPEN LABELLED RANDOMISED CONTROLLED CLINICAL TRIAL’’
Introduction:
Polycystic Ovarian Syndrome [PCOS] is the most common endocrine and metabolic disorder in a woman of
reproductive age. Majority of cases with PCOS are obese/overweight in the population. Obesity or overweight affects
between 38 and 88% of women with PCOS. 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. It is also the most frequent condition for
anovulatory cycles leading to infertility. In Kashyapa Samhita, Lakshanas of Vrithapushpa (anovulation) has been
mentioned in the context of Pushpaghni Jataharini.
Rationality For the Selection of The Topic:
Ashtanga Sangraha has clearly mentioned role of Virechana Karma in Granthi Chikitsa. Granthi is a Bahu Dosha
Janya Vikara, for Prabhuta Dosha in the body Samshodhana therapy is indicated. In Obese PCOS Vata-kapha
predominance is there & there is Aavarana due to kapha Dosha. As Lekhana Basti possesses Lekhana, Pachana,
Ushna and Tikshna properties. It offers Vatakapha Shamaka, Srotoshodhaka and Amapachana actions. Lekhana Basti
lower LH level and normalize the FSH level to encourage the growth and development of follicles in PCOS patient.
Pathadi Choorna is primarily mentioned in treatment of Vata-Kaphaja type of Artava Dushti in Sushruta Samhita
Sharira Sthana,which have shown encouraging results in clinical features of PCOS. Arogyavardhini Rasa possesses
Deepana-Pachana, Tridoshahara, Rasayana, Vrushya, Medovinashini, and Lekhana properties. It is indicated in
Rogadhikara Jwara, Prameha, and Kushtha and is useful in metabolic disorders. As acharya Charaka has mentioned
this Kwatha for Prameha, so considering the Insulin resistance condition in PCOS patient, this drug will be beneficial.
Aims and Objectives
Aim:
1. To evaluate the efficacy of Virechana Karma and Lekhana Basti along with Pathadi Yoga Ghanavati and
Phalatrikadi Kwatha in ovulation induction in obese polycystic ovarian syndrome and compare it with
standard drug Letrozole and Metformin.
Objectives:
1.To assess the effect of Virechana Karma and Lekhana Basti along with Pathadi Yoga Ghanavati and Phalatrikadi
Kwatha in follicular development and ovulation in obese polycystic ovarian syndrome.
2.To assess the effect of Virechana Karma and Lekhana Basti along with Pathadi Yoga Ghanavati and Phalatrikadi
Kwatha on ovarian morphology, obesity and regulation in menstrual pattern.
Materials And Methods: Diagnosed 20 patients of obese PCOS, fulfilling the Rotterdam criteria (2018) from
the O.P.D. of P.T.S.R. Dept. of ITRA, Jamnagar will be screened with transvaginal sonography for anovulation for
two consecutive cycles and patients having anovulatory cycles will be registered for clinical trial.
Results And Discussion: Data generated during the above study will be presented in a systemic methodical
manner as shall be analysed and the section where the important points of the Conceptual study, Clinical study,
Pharmacological study will be discussed.
Follow up periods: Patients will be advised to visit the hospital every 15 days during the treatment period &
every 15 days for 1 Cycles after the treatment as follow-up.
Side Effects:
These drugs have no known unwanted effects. It is possible that it may also cause some problems that we are not
aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A., Jamnagar