| CTRI Number |
CTRI/2025/04/084736 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Management ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Oral medication for PCOS patient for treating irregular periods |
|
Scientific Title of Study
|
A clinical study to evaluate the effect of Latakaranjaadi Yoga in the management of 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 Himanshi Kharya |
| Designation |
Pg Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi
Laxminarayana Nagara
Udupi KARNATAKA 574118 India |
| Phone |
8109227956 |
| Fax |
|
| Email |
himanshikharya0000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suchetha Kumari |
| Designation |
Assistant Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi
Laxminarayana Nagara
Udupi KARNATAKA 574118 India |
| Phone |
9448529574 |
| Fax |
|
| Email |
suchetha.sdm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Himanshi Kharya |
| Designation |
Pg Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda Udupi |
| Address |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi
Laxminarayana Nagara
Udupi KARNATAKA 574118 India |
| Phone |
8109227956 |
| Fax |
|
| Email |
himanshikharya0000@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Himanshi Kharya |
| Address |
Harsha gift centre jhanda bazar Sihora
District Jabalpur
PIN code 483225 |
| 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 Himanshi Kharya |
Sri Dharmasthala Manjunatheshwara hospital |
Sri Dharmasthala Manjunatheshwara College Of Ayurveda Hospital and Research Centre Kuthpady Udupi
Department of Prasuti Tantra Evum Stree Roga
Laxminarayana Nagara Kuthpady- 574118 Udupi KARNATAKA |
8109227956
himanshikharya0000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL CLEARANCE COMMITTEE OF SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA UDUPI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: JATAGHNI/PUTRAGHNI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Latakaranjaadi Yoga , Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ushnodaka ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Subject fulfilling diagnostic criteria of PCOS
Amenorrhea
Anovulation
Hirsutism
Acanthosis nigricans
Polycystic ovaries morphology on ultrasound |
|
| ExclusionCriteria |
| Details |
Any other systemic diseases which interfere with the treatment
Pregnant women and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Latakaranjaadi Yoga in the management of PCOS |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Latakaranjaadi
Yoga in the management of PCOS symptoms |
Usg will be done on the day 90 to note the size of follicle, ovarian volume , endometrial thickness |
|
|
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)
|
23/04/2025 |
| 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="10" 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
|
Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy. It is a common metabolic-endocrine-reproductive disorder. PCOS is a heterogeneous disorder characterized by amenorrhea,oligo-ovulation or anovulation, signs of elevated androgen levels and multiple small ovarian cysts on one or both ovaries. The pathophysiology of PCOS involves primary defects in the hypothalamic-pituitary axis, insulin secretion and action, and ovarian function. Excess insulin stimulates the ovaries to produce large amounts of male hormone, testosterone which may prevent the ovaries from ovulating, thus causing infertility. Long course of disease without any management may reach the extreme in the form of Cardiovascular disorders, Endometrial cancer, hypertension, dyslipidemia, obesity, diabetes mellitus. According to classics, PCOS cannot be correlated to a single entity. As PCOS itself says it is a group of symptoms. In Ayurveda there are many evidences which can mimic the features of Polycystic ovarian syndrome. Yonivyapads like Vandya. Artavavyapads like Nashtartava , Artava kshaya . It can also be correlated with Pushpaghni jaathaharini from Kashyapa Samhita. It leads to dosha dushya dusthi along with Medodushti and it adversely vitiates the Artava of women thus, making her infertile. PCOS is a syndrome for which there is no permanent remission. Ovulation therapies and symptomatic treatments are practiced but complete cure is not attained. So there is increased demand to approach the problem from view of Ayurvedic system. So in this thesis study is planned with the churna of Kuberaksha Beeja Majja, Shunthi, Methika, Rasona, Hingu, Sauvarchala Lavana, and Manjishta. These drugs are having katu, tikta rasa and usna virya, and vatakaphashamaka properties. Some of the drugs are also Mehaghana, and Vrishya in nature. Hence these studied drugs may prove beneficial in the management of PCOS. |