| CTRI Number |
CTRI/2025/01/079627 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Jyothishmathi patra roasted in ghee powdered and administered with durva swarasa in reduced menstruation with poly cystic ovarian syndrome |
|
Scientific Title of Study
|
TO Evaluate the clinical efficacy of ghrita bhrista Jyothishmathi patra with durva swarasa in Artava kshaya in poly cystic ovarian syndrome-A Pilot study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nazeesh parveen banu |
| Designation |
student |
| Affiliation |
sushrutha ayurvedic medical college |
| Address |
opd no 9, ground floor, Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, Jigani ,Bengaluru Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru Bangalore Rural KARNATAKA 560105 India |
| Phone |
8688951170 |
| Fax |
|
| Email |
nazeesh.r2001@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Nazeesh parveen banu |
| Designation |
student |
| Affiliation |
sushrutha ayurvedic medical college |
| Address |
OPD NO 9 , ground floor Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru Bangalore Rural KARNATAKA 560105 India |
| Phone |
8688951170 |
| Fax |
|
| Email |
nazeesh.r2001@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr.Ranjitha BM |
| Designation |
Associate Professor |
| Affiliation |
sushrutha ayurvedic medical college |
| Address |
OPD NO 9, Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru Department of prasooti tantra and stree roga, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru Bangalore Rural KARNATAKA 560105 India |
| Phone |
9480194926 |
| Fax |
|
| Email |
drranjithabm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sushrutha Ayurveda Medical College garden Sushrutha ayurveda medical college and hospital,Prashanti kuteeram,Svyasa Campus Jodi Bingapura, Jigani Hobli,Anekal Taluk bengaluru 560105 Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sushrutha Ayurveda Medial college and Hospital |
| Address |
Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DrRanjitha B M |
Sushrutha Ayurveda Medical College and hospital |
OPD NO 9, Ground floor, Sushrutha Ayurveda Medical College and Hospital, jigani ,Bengaluru Bangalore Rural KARNATAKA |
9480194926
drranjithabm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAMC&H-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: ARTAVAKSHAYAH, (2) ICD-10 Condition:N74||Female pelvic inflammatory disorders in diseases classified elsewhere. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jyothishmathi patra and Durva swarasa, Reference: Bhaishajya Ratnavali chapter 67 , shloka number 28, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Durva swarasa), Additional Information: -ghrita bhrista Jyothishmathi patra |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1. Women of age group between 18-35 years
2. Oligomenorrhea/hypomenorrhea
3. Diagnosed case of polycystic ovaries through USG |
|
| ExclusionCriteria |
| Details |
1. Pelvic inflammatoy disease
2. Abnormal uterine bleeding
3. Fibroid uterus
4. endometriosis
5. Adenomyosis
6. Hormonal disorder except PCOS
7. Congenital anomalies of female genital tract |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study on the clinical effi cacy of ghrita bhrista jyothishmati patra with durva swarasa in managing artava kshaya with in the context of polycystic ovarian syndrome aims to explore an ayurvedic approach to improving menstrual health where there will be Normalcy of duration and regularization of menstrual flow is expected. |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Normalcy of duration and regularization of menstrual cycle |
After 2 months |
|
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
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="0" Months="2" 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
|
Artava Kshaya is described as a condition where there is diminution or reduction in menstrual flow,irregularity or cessation of menstruation and disruption in the normal
menstrual cycle1.PCOS(polycystic ovarian syndrome) is the most common endocrine
disorder in a women of reproductive age.Diagnosis is based upon the presence of any
two of the following criteria 1)Oligoand/anovulation 2)Hyperandrogenism (clinical
and/or biochemical). 3)polycystic ovaries.Ovarian volume increased≥10cm3. Presence
of multiple(≥12)follicles cysts measuring about 2-9mm in diameter around the cortex2.
Incidence of PCOS is estimated to be around 5-10% among women of reproductive age
and Prevalence rates for PCOS range from 6%-20% with variations influenced by factors
such as ethnicity and regional demographics. specific populations, particularly those
with family history of PCOS or associated metabolic conditions may exhibit higher
Prevalence rates3.
Artava Kshaya can be understood as a vata-kaphaja vikara,where vata governs
physiological functions with apana vata ensuring the proper flow of artava. Kapha with
its Avrodhaka guna can block the Artava vaha srotas, contributing the pathogenesis of
Artava Kshaya along with Vata.In Bhaisajya Ratnavali acharya has mentioned that
Jyothishmati patra (Celastrus paniculatus) roasted with Goghrita ground with durva
swarasa (Cynodon dactylon) act as
artavapravartaka4. Jyotishmati ( Celastrus paniculatus) with its katu-tiktarasa,
teekshnaguna, ushnaveerya and katuvipaka helps in vilayana of kapha and alleviating
vata dosha there by clearing obstructions, it also promotes agnivardhana, amapachana,
leading to proper formation of rasadidhatu. since Artava is the upadhatu of
rasadhatu, this process supports proper artava formation5. |