| CTRI Number |
CTRI/2024/08/072804 [Registered on: 21/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of lasuna churna and shatpushpa ghana vati in PCOS |
|
Scientific Title of Study
|
EFFECT OF LASHUNA CHURNA AND SHATAPUSHPA GHANA VATI IN PCOS - AN OPEN LABEL RANDOMIZED COMPARATIVE CLINICAL 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 |
Dr Anjum Maheboobpasha Mujawar |
| Designation |
Post graduate scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysuru, Karnataka
Mysore KARNATAKA 570028 India |
| Phone |
9591928173 |
| Fax |
|
| Email |
anjumujawar27@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vidya Narayan |
| Designation |
Associate Professor |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysuru, Karnataka
Mysore KARNATAKA 570028 India |
| Phone |
9980760076 |
| Fax |
|
| Email |
vidya.dr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anjum Maheboobpasha Mujawar |
| Designation |
Post graduate scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysuru, Karnataka
Mysore KARNATAKA 570028 India |
| Phone |
9591928173 |
| Fax |
|
| Email |
anjumujawar27@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysore, Karnataka, India, 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Anjum Maheboobpasha Mujawar |
| Address |
OPD no. 9, Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road Mysuru, Karnataka
|
| 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 Anjum Maheboobpasha Mujawar |
JSS Ayurveda Medical college and Hospital |
OPD no. 9,Department of Prasooti tantra and stri roga, JSS Ayurveda Medical College and Hospital Lalithadripura road, alanhalli, Mysore, Karnataka , 570028 Mysore KARNATAKA |
9591928173
anjumujawar27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS Ayurveda Medical college and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N00-N99||Diseases of the genitourinary system. 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: Lashuna churna, Reference: Kashyapa Samhita Kalpasthan Lashunakalpa Adhyaya, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: Medicine will be discontinue during cycle | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatapushpa ghana vati, Reference: Kashyapa Samhita Kalpashtana Shatapushpashatavari Kalpa adhyaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: water), Additional Information: Medicine will be discontinue during cycle |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) Subjects with signs and symptoms of PCOS.
2) Subjects aged between 18- 40 years.
|
|
| ExclusionCriteria |
| Details |
1) Subjects already on another drug treatment for PCOS like (OC Pills)
2) Subjects with other functional and structural pathology of reproductive organs.
3) Subjects with known cases of systemic disorders like renal disorders, and metabolic disorders like thyroid dysfunction and gastritis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Regularity of cycle and reduction in acne |
5 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in hirsutism and Acanthosis nigricans |
5 months |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2024 |
| 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="5" 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 is the common health hazard amongst women of reproductive age. It is characterized by oligo-ovulation or
anovulation, features of androgen excess and ultrasound appearance of
polycystic ovary. The prevalence of PCOS, a common female endocrine condition
has been found to range from 2.2% to 26% globally and from 3.7% to 22.5% in
India, depends on the diagnostic criteria utilized. PCOS affects 30-40% of
women with amenorrhea where as it affects 85-90% women with oligomenorrhea.
PCOS affects more than 80% of women who report with signs of
androgen excess.
PCOS is associated with
weight gain, acne, hirsutism and impaired fertility due to chronic
oligo-anovulation. In addition to androgen excess, insulin resistance is a
central feature and women with PCOS have shown to be at increased risk of type
2 Diabetes, Hypertension and fatty liver disease. There are no curative options
currentlyfor PCOS, therefore treatment aims to alleviate symptoms and prevent
long-term complications, including cardiovascular events and endometrial
cancer.
The treatment
available in contemporary science like Hormonal therapy, OC pills,
Insulin therapy, prolonged usage end up with other metabolic
disturbances, weight gain, acne, skin discolouration (acanthosis nigricans) and
serious complications like Pulmonary thrombosis, Genital carcinoma, renal
failure.
In Ayurvedic classics
there areno direct references of this disease rather, symptoms are found under
various diseased conditions at various references, like menstrual
irregularitiesdescribed under the Ashtaartavadushti
,Pushpaghni, Jataharini mentioned in Kashyapa Samhita.
RevatiKalpa Adyaya10bears similar features of
hyperandrogenism like Vruthapushpa(anovulation), Sthoola(obesity), Lomaganda(hirsutism). Sushrutha
Samhita gives the referencein ShukrashonitashuddhiAdhyayaabout Nasthartava ( amenorrhea) due to aggravated Kapha, VattaDosha. In DoshadhatumalakshayavridhiAdhyaya there
is reference about ArtavakshayaLakshanaslike YathochitakalaAdarshanamAlpadarshana(scanty
flow). In Charak
Samhita many scattered references are available in different
chapters. In GarbhavakrantiShareera, there
is mention of Beejadushti which is
characterised by Nashtartava(secondary
amennorhea) and SantarpanaotthaVikarain
the context of Sthoulya has
been described. In AshtangaSangrahaPutarakameeeyaadhyaya there
is description of Anartava. Bhavaprakash under NanatmajaVyadhi Nashtartava has been
explained. It may understood on the basis of Doshadushtiinvolvement of Dushya, Shrotas, Ama, Agani, AdhishthanaandVyadhiLaxanas. Metabolic
process is correlated with Dhatuagnivikara.
Therefore the drug selected for this study is Lashuna and Shatapushpa has
been mentioned in Kashyapa Samhita. Both
the drugs possess Katu Rasa,
UsnaVirya, LaghuTikshnaGuna, KatuVipakaand Vatakapha Hara, which acts as Artavapravartaka, Yonishodhana, Pradara,
Vrushya, Garbhajanaka, Deepana, Pachana Karma. |