| CTRI Number |
CTRI/2025/04/083816 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
29/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect Of Krishnatiladi Kashaya Ghanvati As Emmenagogue In PCOS (Phenotype D) |
|
Scientific Title of Study
|
Efficacy Of Krishnatiladi Kashyam Ghanvati As Artava Janan (Mensturation) In Patients Of Avrita Vata Artava Dushti WSR PCOS (Phenotype D) |
| 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. Shalini Varshney |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic And Unani Tibbia College And Hospital |
| Address |
OPD No 13 and 18
Department Of Dravyaguna
AUTCH
Near Ajmal Khan Park Karol Bagh New Delhi
T 45 Second Floor Ratan Nagar
Gaushala Marg Karol Bagh
New Delhi 110005
Central
DELHI
110005
India |
| Phone |
9354925050 |
| Fax |
|
| Email |
shalinidr.v7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Varshney |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi |
| Address |
Department Of Dravyaguna
Ayurvedic And Unani Tibbia College And Hospital Karol Bagh New Delhi
T 45 Second Floor Ratan Nagar Gaushala Marg Karol Bagh New Delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
09354925050 |
| Fax |
|
| Email |
shalinidr.v7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shalini Varshney |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College and hospital Karol Bagh New Delhi |
| Address |
DEPARTMENT OF DRAVYAGUNA
AYURVEDIC AND UNANI TIBBIA COLLEGE AND HOSPITAL KAROL BAGH NEW DELHI
T 45 Ratan Nagar Gaushala Marg Karol Bagh New Delhi 110005
New Delhi
DELHI
110005
India |
| Phone |
09354925050 |
| Fax |
|
| Email |
shalinidr.v7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi 110005 |
|
|
Primary Sponsor
|
| Name |
The Central Council for Research in Ayurvedic Science |
| Address |
No 61 65 Institutional Area Opposite D Block Janakpuri New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Arzoo Khatoon |
Ayurvedic And Unani Tibbia College And Hospital |
OPD No 13 And 18
Department Of Dravyaguna
Department Of Prasuti Tantra And Stri Roga
Near Ajmal Khan Park Karol Bagh New Delhi Delhi 110005
Central
DELHI |
9540498794
arzoo.khatoon77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Ayurvedic and Unani Tibbia College and Hospital Karol Bagh New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N832||Other and unspecified ovarian cysts. 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: Krishna Tiladi Kashyam ghanvati, Reference: Yogratnakar yonivyapad chikitsa adhyay shloka 14, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: medicine will be given before meal |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
patients having symptoms of PCOS phenotype D
(oligomenorrhoea or anovulation and PCOS without Clinical or biochemical
hyperandrogenism)
2 Artava kshaya and Amenorrhea or oligomenorrhea (cycles greater than 35 days apart or less than 8 cycles per year).
3 Endometrial thickness is greater than 5mm in ultrasonography. |
|
| ExclusionCriteria |
| Details |
1. Female patients having any other disease causing oligomenorrhoea and
anovulation excluding PCOD on the above criteria.
2. Known case of adrenal hyperplasia, severe insulin resistance, androgen
secreting neoplasm, thyroid abnormalities, cushing’s syndrome will be
excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Krishnatiladi kashayam ghanvati may act as emmenogogue |
baseline 7th day and 15th day of both menstrual cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement In Symptoms Of PCOS
Amount Of Menstrual Flow Duration of Menstrual Bleeding
Dysmenorrhea |
Baseline 7th day 15th Day Of Two Consecutive Menstrual Cycle |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
09/04/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a most common metabolic and endocrine disorder in women of reproductive age It affects an estimated 5 to13 percent females and up to 70 percent of women with PCOS worldwide remains undiagnosed Symptoms of PCOS include Amenorrhea or infrequent menstruation irregular bleeding and infrequent or no ovulation and multiple immature follicles. Later complication of PCOS is associated with type 2 diabetes heart disease and ovarian cyst. According to the Rotterdam consensus PCOS is determined by the presence of at least two out of three of the following features: evidence of oligomenorrhea (cycles greater than 35 days apart or less than 8 cycles per year) or anovulation or biochemical or clinical hyperandrogenism and Polycystic ovarian morphology greater than or equal to 12 follicles measuring two to nine mm in diameter and or an ovarian volume greater than10 mL in at least one ovary) . Phenotype D oligomenorrhoea / anovulation and PCOS without Clinical or biochemical hyperandrogenism. In Ayurvedic literature details as per PCOS is not described. It is a syndrome involving Pitta and Kapha and Rasa dhatu Dushti Dhatwagni mandya and Artava Dushti. It has been mentioned in Yogaratnakar Yonivyapchikitsa Adhyaya that after the use of decoction prepared from Krishna Tila (Sesame indicum Linn) Shelu (Cordia dichotoma Forst) and Karvi (Nigella sativa Linn) mensuration will start in three days. Krishna tila and Karvi is having Ushna Veerya these drug may initiate mensuration. So this study may evaluate the efficacy of KrishnaTiladikashayam in dosage form of ghanvati as artavajanan (emmenagogue). It may be more feasible dosage form for artavajanan on the PCOS (Phenotype D ) patients. |