| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (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 | | 2 | Comparator Arm | Drug | Classical | | (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: - |
|
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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.
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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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.
|
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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
|
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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. |