| CTRI Number |
CTRI/2026/02/104504 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Study of Tilshelukarvi yog and Brahmi Ghrit Nasya in the Management of PCOS |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation of the Efficacy of Tilshelukarvi Yog and Brahmi Ghrit Nasya in Management of Pushpaghni Jataharini With Special Refrence to Polycystic Ovarian Syndrome (PCOS). |
| Trial Acronym |
CETB-PCOS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jyotsna |
| Designation |
M.S. Scholar of Prasuti tantra evum stree roga |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Prasuti tantra evum stree roga , State Ayurvedic College and Hospital lucknow.
P.G Department of Prasuti tantra evum stree roga , State Ayurvedic College and Hospital lucknow.
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
8887687313 |
| Fax |
0 |
| Email |
yadavjyotsna1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Srivastava |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Prasuti tantra evum stree roga , State Ayurvedic College and Hospital lucknow.
P.G Department of Prasuti tantra evum stree roga , State Ayurvedic College and Hospital lucknow.
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9838436080 |
| Fax |
0 |
| Email |
jayasrivas541@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Srivastava |
| Designation |
Lecturer |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Prasuti tantra evum stree roga , State Ayurvedic College and Hospital lucknow.
P.G Department of Prasuti tantra evum stree roga , State Ayurvedic College and Hospital lucknow.
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9838436080 |
| Fax |
0 |
| Email |
jayasrivas541@gmail.com |
|
|
Source of Monetary or Material Support
|
| state ayurvedic college and hospital,Tulsidas Marg,Turiyaganj,Lucknow,Uttar Pradesh 226004, India |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
state ayurvedic college and hospital,Tulsidas Marg,Turiyaganj,Lucknow,Uttar Pradesh 226004, India |
| 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 Jyotsna |
State Ayurvedic college and hospital Lucknow |
P.G Department of Prasuti tantra evum stree roga , State Ayurvedic College and Hospital lucknow.
P.G Department of Prasuti tantra evum stree roga , State Ayurvedic College and Hospital lucknow.
Lucknow
UTTAR PRADESH |
08887687313
0
yadavjyotsna1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee, State Ayurvedic College and Hospital, Lucknow |
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 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Charak samhita sidhhi sthan, Procedure details: Purvakarma
Patient is examined & suitable medicated oil like Brahmi ghrita is selected. Oil massage & mild steam are given on face & neck to loosen doshas & open channels.
Pradhana Karma
Patient lies on back with head slightly tilted. Lukewarm medicated oil four to six drops is put in each nostril. Gentle massage is done. Patient spits out mucus without swallowing.
Paschat Karma
Patient rests for few minutes. Avoid cold, heavy work, loud talking. Light & warm diet is advised. Mild massage & steam may be given again.)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tilshelukarvi yog, Reference: Yog ratnakar yonivyapad chikitsa , Route: Oral, Dosage Form: Khanda /Granules, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Females who are in age group 18-40 years.
2 Patients having menstrual irregularities in terms of flow, duration and interval.
3 Patients having polycystic ovaries diagnosed by USG.
4 Patients showing other symptoms of PCOS i.e. facial hairs, acne, obesity, scalp hair loss
etc.
5 Patients who are willing for trial |
|
| ExclusionCriteria |
| Details |
1 Patients of age below 18 and above 40 years of age.
2 Patients having any genetic or congenital deformities or having any other disease causing
oligomenorrhea and anovulation.
3 Any pelvic pathology TB or carcinoma.
4 Patients suffering from systemic disorders like hypertension,Diabetes,
hyperprolactinemia, adrenal hyperplasia, thyroid abnormalities, and cardiac diseases are
excluded.
5 Current or previous ,within last 3 months use of OCP pills, gluco-corticoids, anti
androgens, ovulation inducing drugs, or any other hormonal drugs.
6 Post-menopausal stage. |
|
|
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 |
1.To explore and evaluate the efficacy of oral use of Tilshelukarvi yog in the management of
Polycystic Ovarian syndrome, with a focus on restoring hormonal balance, regularizing
the menstrual cycle, and improving overall reproductive health.
2.Clinical evaluation of the efficacy of Brahmi Ghrita nasya in management of PCOS .
3.To see recurrence rate/ side effects if occur .
|
Follow up during trial at the end of
every month and 1 month
after completion of trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To explore & evaluate the efficacy of oral use of Tilshelukarvi yog in the management of
Polycystic Ovarian syndrome, with a focus on restoring hormonal balance, regularizing
the menstrual cycle, & improving overall reproductive health.
2.Clinical evaluation of the efficacy of Brahmi Ghrita nasya in management of PCOS .
3.To see recurrence rate/ side effects if occur .
|
Follow up during trial at the end of
every month & 1 month
after completion of trial. |
|
|
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 |
|
Date of First Enrollment (India)
|
01/04/2026 |
| 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="1"
Months="5"
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
|
This synopsis is a comparative clinical study conducted by Dr. Jyotsna M.S. Ayurveda, Prasuti Tantra & Stri Roga to evaluate the effectiveness of Tilshelukarvi Yog and Brahmi Ghrit Nasya in the management of Polycystic Ovarian Syndrome, which is correlated in Ayurveda with Pushpaghni Jataharini described in Kashyapa Samhita. PCOS is a common hormonal disorder causing irregular menstruation, obesity, excess hair growth, and infertility. According to Ayurveda, it occurs due to imbalance of Vata and Kapha dosha, Agnimandya , and blockage of Artavavaha Srotas. In this randomized comparative clinical study, 40 patients aged 18 to 40 years will be divided into two groups: one receiving Tilshelukarvi Yog orally and the other receiving Tilshelukarvi Yog along with Brahmi Ghrit Nasya therapy. The study will assess improvement in menstrual regularity, hormonal levels, ovarian changes, BMI, and associated symptoms. The aim is to provide a safe, non-hormonal, and effective Ayurvedic approach for long-term management of PCOS with minimal side effects |