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CTRI Number  CTRI/2023/05/052924 [Registered on: 19/05/2023] Trial Registered Prospectively
Last Modified On: 16/05/2023
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   Erandamuladi Niruha Basti and Madhutailik Basti in the Management of Polycistic Ovarian Syndrome in the Reproductive age women. 
Scientific Title of Study   RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFECT OF ERANDAMULADI NIRUHA BASTI AND MADHUTAILIK BASTI IN THE MANAGEMENT OF POLYCYSTIC OVARIAN SYNDROME IN THE REPRODUCTIVE AGE WOMEN. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SANDHYA MADHUKAR YENNAWAR 
Designation  PhD Scholar 
Affiliation  PMTs Ayurved Medical College and Shri Eknath Ayurved Rugnalaya 
Address  Prasutitantra and Strirog Department, OPD no.7, IPD no.3, PMTs Ayurved Medical College and Shri Eknath Ayurved Rugnalaya, Shevgaon, Ahmednagar, Maharashtra

Ahmadnagar
MAHARASHTRA
414502
India 
Phone  9850562524  
Fax    
Email  dryennawar11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PRAKASH RAMBHAU KANADE 
Designation  Professor and HOD  
Affiliation  PMTs Ayurved Medical College and Shri Eknath Ayurved Rugnalaya 
Address  Prasutitantra and Strirog Department, OPD no.7, IPD no.3, PMTs Ayurved Medical College and Shri Eknath Ayurved Rugnalaya, Shevgaon, Ahmednagar, Maharashtra

Ahmadnagar
MAHARASHTRA
414502
India 
Phone  9881413123  
Fax    
Email  prkanade73@gmail.com  
 
Details of Contact Person
Public Query  
Name  SANDHYA MADHUKAR YENNAWAR 
Designation  PhD Scholar 
Affiliation  PMTs Ayurved Medical College and Shri Eknath Ayurved Rugnalaya 
Address  Prasutitantra and Strirog Department, OPD no.7, IPD no.3, PMTs Ayurved Medical College and Shri Eknath Ayurved Rugnalaya, Shevgaon, Ahmednagar, Maharashtra

Ahmadnagar
MAHARASHTRA
414502
India 
Phone  9850562524  
Fax    
Email  dryennawar11@gmail.com  
 
Source of Monetary or Material Support  
PMTs Ayurved Medical College and Shri Eknath Ayurved Rugnalaya, Shevgaon, Ahmednagar 414502 
 
Primary Sponsor  
Name  SANDHYA MADHUKAR YENNAWAR 
Address  PMTs Ayurved Medical College and Shri Eknath Ayurved Rugnalaya, Shevgaon, Ahmednagar, Maharashtra 
Type of Sponsor  Other [self] 
 
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 SANDHYA MADHUKAR YENNAWAR  Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidalaya and Rugnalaya  Room no:19(OPD), IPD: Ward no. 28, Prasutitantra and Strirog Department, Chatrapati Shahu Maharaj Shikshan Sansthas Ayurved Mahavidalaya and Rugnalaya,Kanchanwadi, Paithan Road Aurangabad, 431011
Aurangabad
MAHARASHTRA 		 9850562524

dryennawar11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PMT/AYU-PHD/IEC04/STR14  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: POLYCYSTIC OVARIAN SYNDROME, (2) ICD-10 Condition: E282||Polycystic ovarian syndrome,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Charak Siddhisthan 3/38-40, Procedure details: Erandadimula Niruha Basti, 8 days ( per day 1))
(1) Medicine Name: Panchakolchurna, Reference: Bharatbhaishajya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 7 Days
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Sharangadhar Samita Uttarakhanda 6/28-30, Procedure details: Madhutailik Basti,8 days (per day 1))
(1) Medicine Name: Panchakolchurna, Reference: Bharatbhaishajya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  Diagnosed cases ofPCOS (by Rotterdam criteria)- Any 2/3.
a. Hyperandrogenism (Clinical or biochemical).
b. Oligomenorrhea (menstrual cycle >35 days)/ Secondary amenorrhea
(menstrual cycle >90 days but < 180 days).
c. USG findings- PCO features on USG i.e. peripherally Arranged Antral Follicle Count >12 with thickened stroma in ovaries and/or Ovarian volume >10 cm 3 in Unilateral or Bilateral ovaries.

Patient fit for basti. 
 
ExclusionCriteria 
Details  A. Patient of age group <18 and >35years.

B. Patients showing sign & symptoms other than PCOS.

C. Patient having any other disease causing oligomenorrhea and anovulation excluding PCOS on above criteria i.e.Hypogonadotrophic hypogonadism, premature ovarian failure.

D. Known cases of
a) Congenital adrenal hyperplasia
b) Severe insulin resistance (insulin dependent diabetes mellitus)
c) Androgen secreting ovarian and adrenal tumors d) Thyroid abnormalities
e) Cushing syndrome
f) Cardiac disease
g) Hyperprolactinemia.

E. Patient with any organic lesions of reproductive tract like TB, CA,
Congenital anomalies, any other pelvic pathologies.

F. A current or previous (within 3 months) use of OC Pills, glucocorticoids, antiandrogens, antidiabetics, anti-obesity drugs or any
hormonal therapy.

G. Pregnant patients. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Follicular growth (Ovulation)  Baseline - 4 weeks, 8 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Hirsutism, Acne, Obesity (BMI), Hormonal estimation   Baseline - 4 weeks, 8 weeks and 12 weeks 
 
Target Sample Size   Total Sample Size="140"
Sample Size from India="140" 
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)   29/06/2023 
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="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The polycystic ovarian syndrome is a common endocrine disorder affecting women in their reproductive age group with a 6-10% prevalence rate. It was first described by Stein and Leventhal in 1935, called Stein and Leventhal syndrome. It is characterised by a combination of hyperandrogenism either clinical or biochemical, chronic anovulation and polycystic ovaries. It is frequently associated with insulin resistance and obesity. It is the best known and most extensively studied cause of an ovulatory infertility in the reproductive age women.

The conditions which are mentioned in various contexts in ayurvedic classics under various headings as Artavkshaya, Anartava, Nastrartava, Vyandyayonivyapad, PushpaghniJataharini, ShushkarevatiJataharini, Sthoulya, Prameha, Strotodushti, and Santarpannothavyadhi can be to some extent compared with the symptoms of PCOS which needs to be analysed as per ayurvedic parlance.
According to Ayurveda PCOS is the condition of “Bahudoshadushyaavastha”. When there is bahudoshadushyaavastha symptoms are multiple. So, the treatment includes shodhana (bio-purification) chikitsa which is the main concern of Ayurveda to eradicate the disease and long lasting basis by striking at the root of disease (pathology).

According to Charaka, vata is the main causative factor in the manifestations of all types of yoniroga, so it should be treated first by shodhanachikitsa. Basti karma is considered as the main shodhanachikitsa. Basti is the multi- dimensional treatment procedure offering wide range of clinical benefits in different diseases. This extra ordinary therapeutic action is possible due to “Nanavidha dravya sanyogyat”. According to Sushruta, basti is effective in divergent fields of medicine like infection, immunological, auto-immune, degenerative, infertility, metabolic, endocrine and neurological diseases. Basti exerts action in the shakhagata, koshthagata, tiryagata, aavranjanyarogas and equally effective in bahudoshaavastha. Basti is ashukaari in action for eg., Niruhabasti takes only few minutes to act while vamana and virechana take few hours as basti is directly administered in the main seat of vata. So, it is known as “Upakramanam Sarvesham Sagranee”. So, most of the drugs in Erandamuladiniruhabasti are Katu, Kashaya, Tiktarasatmaka, sukshma, tikshnagunatmaka, ushnaviryatmaka, katuvipaki. As well as deepaniya, pachaniya, anulomana, kapha vatahara, agnigunavardhaka, aartavjanan, medohara, shothahara, pramehaghna, kushthaghna, vrushya, granthivilayana in properties this will be beneficial in sampraptivighatana of PCOS. Hence, a prompt attempt is made to study the effect of shodhanachikitsa in PCOS i.e. Erandmuladi Niruha Basti and Madhutailik Basti in this research study.
 
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