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CTRI Number  CTRI/2024/12/078810 [Registered on: 31/12/2024] Trial Registered Prospectively
Last Modified On: 17/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Effect of Vamana (Panchakarma therapy) and Kuberaksha Vati on hormonal profile of Polycystic ovarian syndrome (PCOS)Patients 
Scientific Title of Study   A clinical trial to evaluate the efficacy of Vamana karma along with Kuberaksha vati on PCOS profile in the patients of Polycystic ovarian syndrome 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Pradip Karande 
Designation  PG Scholar 
Affiliation  Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi 
Address  Department of Panchakarma, Ayurvedic And Unani Tibbia College And Hospital ,Ajmal Khan Road ,Karol Bagh, New Delhi 110005

Central
DELHI
110005
India 
Phone  7507854872  
Fax    
Email  anjl.krnd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manoj K Shamkuwar 
Designation  Head Of Department 
Affiliation  Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi 
Address  Department of Panchakarma, Ayurvedic And Unani Tibbia College And Hospital ,Ajmal Khan Road ,Karol Bagh, New Delhi 110005

Central
DELHI
110005
India 
Phone  9354925019  
Fax    
Email  manojshamkuwar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anjali Pradip Karande 
Designation  PG Scholar 
Affiliation  Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi 
Address  Department of Panchakarma, Ayurvedic And Unani Tibbia College And Hospital ,Ajmal Khan Road ,Karol Bagh, New Delhi 110005

Central
DELHI
110005
India 
Phone  7507854872  
Fax    
Email  anjl.krnd@gmail.com  
 
Source of Monetary or Material Support  
Department Of Panchakarma Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi 110005 
 
Primary Sponsor  
Name  Ayurvedic And Unani Tibbia College And Hospital  
Address  Ajmal Khan road,block 56, Karol Bagh New Delhi 110005 
Type of Sponsor  Government medical college 
 
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 Anjali Pradip Karande  Ayurvedic And Unani Tibbia College And Hospital   OPD number 2,department of panchakarma, Ajamal Khan Road ,Block 56,Karol bagh New Delhi 110005
Central
DELHI 
7507854872

anjl.krnd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Ayurvedic And Unani Tibbia College And Hospital  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: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Sushruta Sushruta Samhita volume 1 edited with Ayurveda tatvasandeepika by Kavirajaambika data shastri, samsthan Varanasi reprint 2015 Sutrasthan 15 shloka 16 pg no 77, Procedure details: Pachana will be done using chitrakadi vati followed by snehapana with phala ghritam Then sarvanga abhyanga using murchhita tila taila and sarvanga swedana dashmula vashp sweda will be given Vamana karma will then be performed using madanphala pippali churna madhu saindhava lavana and vacha churna followed by samsarjana krama for 3 or 5 or7 days as per the shuddhi.)
(1) Medicine Name: Kuberaksha Vati, Reference: Dhattaram Srikrishnalal Bruhatnighanturatnakar Khemraj Srikrishndas publication 2019 chapter 23 Vol V P 653, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 120 Days
2Comparator ArmDrugClassical(1) Medicine Name: Kuberaksha Vati, Reference: Dhattaram Srikrishnalal Bruhatnighanturatnakar Khemraj Srikrishndas publication 2019 chapter 23 Vol V P 653, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 120 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Patients with any 2 or more clinical features of PCOS like-
Amenorrhea or Oligomenorrhoea
Clinical hyperandrogenism (acne, hirsutism)
Polycystic Ovaries on USG.
and Patients fit for Vamana Karma.
 
 
ExclusionCriteria 
Details  1. Patients who are contraindicated for vamana karma such as kshatkshina, atishtula,atikrusha,bala,vriddha,durbala,shranta,pipasita .
2. Patients suffering from Pelvic diseases like Endometriosis, PID, Fibroid uterus.
3. Organic lesions of reproductive tract like tuberculosis, carcinoma and congenital deformities.
4. Patients with renal or hepatic impairment (Sr. creatinine more than 1.8mg/dl along with Sr. Urea more than 60 mg/dl, SGOT and SGPT more than Five times of upper limit . Patients having LDL and Triglycerides more than two times of upper limit.
5. Patients with co-morbid conditions such as Hypertension grade 2 (more than equal to 160/100mm of Hg) or more, Diabetes Mellitus (having HbA1c more than 7.5% with or without hyperglycemic medications.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The proportion of patients showing effect on PCOS Profile.  Baseline,after vamana including sansarjana krama,Day 120. 
 
Secondary Outcome  
Outcome  TimePoints 
1) The proportion of patients showing effect on status of menstruation (duration, interval, pain associated with menses), hirsutism, acne.
2) The proportion of patients showing effect on weight, BMI (body mass index), waist-hip ratio, lipid profile.
3)The proportion of patients showing effect on ovulation.
 
Baseline,after vamana,after 1st menstrual cycle,after 2nd menstrual cycle,day 120.
Follicular study will be done every 10th,12th, 14th, 16th, 18th day of cycle for 2 consecutive cycles.
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/02/2025 
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  

Now a days PCOS is rapidly raising globally due to sedentary lifestyles, lack of exercise, more intake of junk food, stressful life etc. However, Infertility, Diabetes mellitus, Endometrial cancer, Metabolic Syndrome, Endometrial Hyperplasia, Hypertension and Cardiovascular disease are the most worrisome medical outcomes. Current modern medical and surgical treatments for PCOS have many limitations like use of metformin for insulin resistance, ovulation induction agents like clomiphene citrate, human menopausal gonadotropins (HMG), laparoscopic ovarian drilling for ovulation induction, OCP (Oral Contraceptive Pills) etc. No single definitive and successful modalities are known to the day. In order to overcome these limitations and invasive therapies with side effects an effective treatment empowered by the principles and practice of Ayurveda is essential.Due to the multifactorial etiology and involvement of Dosha Dushya Sammurchhana at the cellular level, Shodhana is essential part of Ayurvedic management of PCOS along with Shamana. Numerous databases were explored through, but effect of vamana karma along with kuberaksha vati on PCOS profile in patients of PCOS have not been well studied yet.  So, to establish a standard of care in PCOS, the current study  has been planned with all previous hypothesis in mind as well as the findings of previous research studies. By this, we will have a deeper understanding of the changes that ’vamana karma’ along with kuberaksha vati brings about on the various hormones in PCOS patients, we will eventually be able to collect evidence based data on how vamana along with kuberaksha vati is effective in the management of PCOS from the novel perspective of the PCOS profile. 

 

 
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