| CTRI Number |
CTRI/2025/01/079553 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| 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
|
TO SEE THE EFFECT OF AYURVEDIC FORMULATION AND PROCEDURE IN THE MANAGEMENT OF POLYCYSTIC OVARIAN SYNDROME (PCOS) |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABELLED CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF TRIPHLADI TAILAM MATRA BASTI AND KUBERAKSH VATI IN THE MANAGEMENT OF POLYCYSTIC OVARIAN SYNDROME (PCOS) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pooja |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute for Ayurved Studies and Research Umri Road sector 08 |
| Address |
Opd no 15 Department of Prasuti Tantra evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08
Kurukshetra
HARYANA
136118
India |
| Phone |
9992416017 |
| Fax |
|
| Email |
pujajangra121@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suniti Tanwar |
| Designation |
Associate Professor |
| Affiliation |
Institue for Ayurved Studies and Research Umri Road Sector 08 |
| Address |
Room No 113 Department of Prasuti Tantra evam Stree Roga Institue for Ayurved Studies and Research Umri Road Sector 08
Kurukshetra
HARYANA
136118
India |
| Phone |
9996311778 |
| Fax |
|
| Email |
drsunititanwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja |
| Designation |
MS Scholar Prasuti Tantra Evam Stree Roga |
| Affiliation |
Institute for Ayurved Studies and Research Umri Road sector 08 |
| Address |
Opd no 15 Department of Prasuti Tantra evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08
Kurukshetra
HARYANA
136118
India |
| Phone |
9992416017 |
| Fax |
|
| Email |
pujajangra121@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institue for Ayurved Studies and Research Umri Road Sector 08 Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Dr Pooja |
| Address |
Opd no 15 Department of Prasuti Tantra evam Stree Roga Institute for Ayurved Studies and Research Umri Road sector 08 |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Pooja |
Institute for Ayurved Studies and Research Umri Road sector 08 |
Opd no 15 Department of Prasuti Tantra evam Stree Roga Institute for Ayurved Studies and Research Umri Road
Kurukshetra
HARYANA |
9992416017
pujajangra121@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N926||Irregular menstruation, unspecified. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: kuberaksh vati, Reference: Brihat Nighantu Ratnakar Shooladhyaya Chapter 23 volume 5 page no 653, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -koshana jal), Additional Information: - | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: sushrut samhita, Procedure details: 60 ml of Triphaladi tailam for 7 days)
(1) Medicine Name: Triphaladi tailam, Reference: Sushruta samhita Chikitsa adhyay 37 shlok no 33 to 35, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Patient willing to give voluntary informed consent
2 Female patient of age group between 16-40 years (both married and unmarried)
ASRM / ESHRM (Rotterdam) criteria-
Affected patient must follow two out of three criteria
(1) Oligo and/or anovulation
(2) Hyperandrogenism (clinical / biochemical)
(3) Polycystic ovaries (confirmed or USG)
3 BMI more than 24.9 |
|
| ExclusionCriteria |
| Details |
1 Patient who is not willing to give voluntary informed consent
2 Women of age from 16years to 40 years
3 BMI less than 24.9
4 Patient with chronic systemic illness (cardiac failure cirrhosis of liver hypertension
diabetes mellitus tuberculosis chronic renal disease)
5 Patient with reproductive system abnormalities (excluded clinically and radiologically
hydrosalpinx endometrosis adenomyosis carcinoma of reproductive organ)
6 Long term medication
7 Any type of malignancy
8 Patient with positive STDs HIV Hepatitis B antigen (HBsAg)
9 Patient suffering from adrenal hyperplasia severe insulin resistant androgen secreting
neoplasm thyroid abnormalities cushing syndrome |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce or resolve the number and size of cyst |
FOLLOW UP FOR SUBJECTIVE SYMPTOMS AFTER EVERY 1 MONTH AND FOR OBJECTIVE SYMPTOMS AFTER 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in other associated clinical feature related to Polycystic ovarian syndrome (PCOS) |
FOLLOW UP FOR SUBJECTIVE SYMPTOMS AFTER EVERY 1 MONTH AND FOR OBJECTIVE SYMPTOMS AFTER 3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/02/2025 |
| 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
|
Polycystic ovarian syndrome (PCOS) is a endocrinopathy typified by oligoovulation or anovluation , signs of androgen excess and multiple small ovarian cysts.1 These signs and symptoms may very widely between women as well as within individuals over time. Risk factors that predispose females to Polycystic ovarian syndrome ( PCOS ) are lifestyle or diet, environmental pollutants, genetics , gut dysbiois neuroendorcine alternations and obesity. Obesity is a commom finding in women with Polycystic ovarian syndrome( PCOS) and between 40-80% of women with this condition are reported to be overweight or obese.2 Polycystic ovarian syndrome (PCOS) appears to equally affect all races and nationalities. The Rotterdam criteria constitute a broader spectrum that put forward by NIH (National Institutes of Health) [ESHRE/ASRM (Rotterdam) 2003]3 - It includes two out of three of the following 1 Oligo or annovulation. 2 Clinical and or biochemical signs of Hyperandrogenism . 3 Polycystic Ovaries (with exclusion of related disorders). As there is no direct mentioning of a diseases in Ayurveda which is having direct correlation with any modern diseases but all the modern diseases can be included under the broad umbrella of Ayurvedic technologies. Polycystic ovarian syndrome (PCOS) is a problem including 2 unevenness of vata and kapha mainly. |