| CTRI Number |
CTRI/2025/01/079442 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of menstrual irregularity |
|
Scientific Title of Study
|
A single arm clinical trial to evaluate the effect of Koshtashodhana and Haridradigana ghana vati in the management of Artavadosha associated with Non-Hyperandrogenic Polycystic Ovary 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 |
Dr Sulekha |
| Designation |
PG Scholar |
| Affiliation |
Shri Dhanwantry Ayurvedic College and hospital sector 46 B Chandigarh,160047 India |
| Address |
Room No. 205 ,second floor,Department of Prasuti Tantra evam Stree Roga ,Shri Dhanwantry Ayurvedic College and Hospital Sec 46 B Chandigarh,India
Chandigarh
CHANDIGARH
160047
India |
| Phone |
08168395102 |
| Fax |
|
| Email |
sulekhasaini120@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana S |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic college and Hospital Sec 46B Chandigarh |
| Address |
Room No. 205 ,second floor,Department of Prasuti Tantra evam Stree Roga ,Shri Dhanwantry Ayurvedic College and Hospital Sec 46 B Chandigarh,India
Chandigarh
CHANDIGARH
160047
India |
| Phone |
9447767909 |
| Fax |
|
| Email |
archanas875@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana S |
| Designation |
Associate Professor |
| Affiliation |
Shri Dhanwantry Ayurvedic college and Hospital Sec 46B Chandigarh |
| Address |
Room No. 205 ,second floor,Department of Prasuti Tantra evam Stree Roga ,Shri Dhanwantry Ayurvedic College and Hospital Sec 46 B Chandigarh,India
CHANDIGARH
160047
India |
| Phone |
9447767909 |
| Fax |
|
| Email |
archanas875@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dhanwantry Ayurvedic college and Hospital sector 46B Chandigarh 160047 |
|
|
Primary Sponsor
|
| Name |
Dr Sulekha |
| Address |
Shri Dhanwantry Ayurvedic college and Hospital sector 46B Chandigarh 160047 India |
| 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 Sulekha |
Shri Dhanwantry Ayurvedic college and Hospital sector 46B Chandigarh India 160047 |
Room No 105 1st floor,Prasuti Tantra evam Stree Roga Shri Dhanwantry Ayurvedic College and Hospital Sector 46B Chandigarh India
Chandigarh
CHANDIGARH |
08168395102
sulekhasaini120@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Dhanwantry Ayurvedic College And Hospital Sector 46B Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gandharvahasthadi tail , Reference: Ashtanga sangraha 15/21, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: sos, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Milk), Additional Information: -Weekly once at night | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haridradigana , Reference: Ashtang hridyam 15/35, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married and unmarried females willing to take part in study
BMI more than or equal to 18.5 kg/m2 to less than or equal to 35kg/m2
Interval of menstrual cycles- 38 to 90 days in the past 2 cycles or less than 9 menstrual periods in one year
Already diagnosed and newly diagnosed patients of PCOS with phenotype D
(non –hyperandrogenic PCOS)
Patients who have informed written consent |
|
| ExclusionCriteria |
| Details |
Subjects with Hyperthyroidism and uncontrolled hypothyroidism
Subjects taking any hormonal medication from last three months at the time of screening
Subjects with Hyperprolactinemia having Serum Prolactin more than 30 ng/ml
Subjects with Hyperandrogenism Serum Testosterone level more than 0.6ng/ml
Subjects with Modified Ferriman Gallway Score more than 8
Subjects having uncontrolled hypertension BP more than 130/90mmHg and DM II FBS more than 150mg/dl
Subjects suffering from any kind of congenital disease for example congenital adrenal hyperplasia
Subjects having any pelvic pathologies like androgen secreting tumours uterine fibroid endometriosis adenomyosis pelvic inflammatory diseases etc
Pregnant lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in inter-menstrual interval |
baseline to 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in ovarian volume
Reduction in no. of cysts in ovary
Decrease in Fasting blood sugar level |
Baseline to 90th day |
|
|
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)
|
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="3"
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
|
PCOS is characterized by irregular menstrual cycles (oligomenorrhea/Amenorrhea), anovulation, acne, hirsutism, obesity with distinct abdominal obesity and infertility. Modified Rotterdam criteria as most accepted criteria for diagnosis of PCOS requiring presence of any two conditions out of three - oligomenorrhea and/or Amenorrhea, hyperandrogenism (clinical and/or biochemical) ,Polycystic ovaries diagnosed by USG accompanied with detailed description of four types of phenotypes(A,B,C and D). Phenotype D includes ovulatory dysfunction (Oligomenorrhea/Amenorrhea) and polycystic ovarian morphology(≥ 12 follicles in any one ovary measuring 2-9mm and ovarian volume >10cm2 ).This study aims to evaluate the effect of Koshtashodhana and Haridradigana ghana vati be in the management of Artavadosha associated with Non-Hyperandrogenic Polycystic ovary Syndrome. This study involves single group study with 40 patients. Primary Expected Outcome of study is reduction in inter-menstrual interval and Secondary Expected Outcome to be reduction in ovarian volume,reduction in no. of cysts in ovary and decrease in Fasting blood sugar level. |