| CTRI Number |
CTRI/2025/10/095661 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| 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
|
A study to compare the effects of Chandrashoor Churna and Metformin, along with diet and lifestyle changes, in managing irregular menstrual cycles in women with PCOS |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Chandrashoor Churna versus Tablet Metformin with dietary and lifestyle modifications in both groups in the Management of Artavakshaya (Oligomenorrhoea in Polycystic Ovarian Syndrome): A Randomised Control Trial |
| 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 Disha Sudhakar Shetty |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre ,Salod Wardha |
| Address |
Opd no-09,Stree Roga Evam Prasuti Tantra Department, Mahatma Gandhi Ayurveda College,Hospital and Research Centre,
Salod Wardha Maharashtra-442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8828290048 |
| Fax |
|
| Email |
dishashetty1723@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhagyashri Chaudhari |
| Designation |
Associate Professor |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre ,Salod Wardha |
| Address |
Opd no-09,Stree Roga Evam Prasuti Tantra Department, Mahatma Gandhi Ayurveda College,Hospital and Research Centre,
Salod Wardha Maharashtra-442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096415920 |
| Fax |
|
| Email |
drbhagyashrichaudhari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Disha Sudhakar Shetty |
| Designation |
PG SCHOLAR |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre ,Salod Wardha |
| Address |
Opd no-09, Stree Roga Evam Prasuti Tantra Department, Mahatma Gandhi Ayurveda College,Hospital and Research Centre,
Salod Wardha Maharashtra-442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
8828290048 |
| Fax |
|
| Email |
dishashetty1723@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College,Hospital and Research Centre,
salod wardna Manarashtra-442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurved college, Hospital and Research Centre |
| Address |
Opd no-09 Mahatma Gandhi Ayurveda College,Hospital and Research Centre,
salod Wardha Maharashtra-442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Disha Sudhakar Shetty |
Mahatma Gandhi Ayurveda College Hospital and Research Centre |
Opd no-09,Stree Roga Evam Prasuti Tantra, Mahatma Gandhi Ayurveda College,Hospital and Research Centre,
salod wardna Manarashtra-44zuul
Wardha
MAHARASHTRA |
8828290048
dishashetty1723@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College,Hospital and Research Centre Institutional Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chandrashur choorna, Reference: Bhavprakash Purva Khanda Haritakyadi varga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Tablet Metformin | Metformin belongs to the biguanide class (The molecular formula of Metformin IUPAC Name: N,N dimethylimidodicarbonimidic diamide) of oral antidiabetic agents and is mainly used for the management of type 2 diabetes mellitus and polycystic ovarian syndrome (PCOS). Along with the active ingredient, the tablet also contains certain inactive substances (called excipients) that help in binding, stability, and proper absorption. These may include microcrystalline cellulose as a filler, povidone as a binder, magnesium stearate as a lubricant, and hypromellose or titanium dioxide for coating and appearance. The actual formulation may vary slightly depending on the brand, but the therapeutic effect is entirely due to Metformin Hydrochloride, while the excipients ensure the tablet’s quality, stability, and patient acceptability. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Females aged 18 35 years Diagnosed with PCOS based on USG Presenting with symptoms of Oligomenorrhoea
Presenting with symptoms of Artavakshaya Scanty menstrual flow Informed consent given
|
|
| ExclusionCriteria |
| Details |
Women with secondary causes of amenorrhea eg hypothyroidism hyperprolactinemia premature ovarian failure Presence of structural abnormalities eg fibroids endometriosis or tubal blockagesKnown cases of Type 1 or Type 2 diabetes mellitus Thyroiddysfunction Hyperprolactinemia Cushings syndrome Women on Hormonal therapy OCPs HRT etc Antidiabetic antiobesity or steroidal drugs in the past 3 months Lactating women or who want to conceive during this period Known allergy or intolerance to Chandrashoor or Metformin History of chronic illnesses affecting reproductive health (e.g renal failure, liver disease) Participation in any other clinical trial within the last 3 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Chandrashoor Churna with dietary and lifestyle regimen in the Management of Artavakshaya (Oligomenorrhoea in polycystic ovarian syndrome)
|
0 week,4 week, 8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the improvement in menstrual irregularities, reduction in pain in both groups. |
3 months (2 consecutive menstrual cycle ) during study With 3 months (2 consecutive menstrual cycle ) follow up after study
|
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per a computer-generated table. The clinical research format will be prepared and validated. Before the study approval is taken from lEC, MGACHRC, Salod (H) Wardha, and CTRI registration will be done. After selection, each participant will be tested individually and selected according to the selection criteria. They are divided into two groups. The trial is a Randomized Control Clinical Trial. |