| CTRI Number |
CTRI/2024/04/066442 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of Cap.Saptarangi in insulin resistance associated with obesity. |
|
Scientific Title of Study
|
A single arm study of PCOS to evaluate efficacy of Cap.Saptarangi in insulin resistance associated with obesity. |
| 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 Prajakta Sharad Machale |
| Designation |
PG scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College,Post Graduation Research Centre Ashta |
| Address |
Strre Rog Prasuti Tantra OPD Ground Floor Dhanvantari Ayurvedic Hospital Ashta ,
Tal-Walwa, Dist - Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7057761311 |
| Fax |
|
| Email |
prajaktamachale65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tinku Ganesh Prabhu Khalche |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College,Post Graduation Research Centre Ashta |
| Address |
3 rd Floor Department Of Stree Rog Prasuti Tanta Hon Shri Annasaheb Dange Ayurvedic Medical College,Post Graduation Research Centre Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
919423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tinku Ganesh Prabhu Khalche |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College,Post Graduation Research Centre Ashta |
| Address |
3 rd Floor Department Of Stree Rog Prasuti Tanta Hon Shri Annasaheb Dange Ayurvedic Medical College,Post Graduation Research Centre Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
919423041730 |
| Fax |
|
| Email |
tinkuganeshkhalache@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurvedic Medical College Post Graduation Research Centre |
|
|
Primary Sponsor
|
| Name |
Hon Shri Annasaheb Dange Ayurvedic Medical College Post Graduation Research Centre Astha |
| Address |
Hon Shri Annasaheb Dange Ayurvedic Medical College Post Graduation Research Centre Astha |
| Type of Sponsor |
Private 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 Prajakta Sharad Machale |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 8 Prasuti Tantra Stri Rog OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
7057761311
prajaktamachale65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurvedic Medical College Post Graduation Research Centre Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N830||Follicular cyst of ovary. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Cap.Saptrangi, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Patient age group from 20-45 years (upto menopause).
2) Including Both unmarried & married patients.
3) All obese patients with BMI 30 and above.
4) An Obese patients with irregular menses With scanty bleeding.
5) Obesed patients with Increased Random BSL. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A single arm study of PCOS to evaluate efficacy of Cap.Saptarangi in insulin resistance associated with obesity. |
13 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Regular menses |
3 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
10/05/2024 |
| 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="1"
Months="6"
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
|
In this modern era, the sedentary life, faulty food habits, stress, lack of physical exercise etc. affects the health of a woman & ultimately it leads to menstrual abnormalities.
Today menstrual abnormalities is a rising problem ,Ayurveda links the causes of PCOS with the over- consumption of kaphagenic (Kapha aggravating) foods or foods which are juicy and sweet. These foods overwhelm the digestive tract with sugar and fluid and weaken it during the process. Ayurveda also believes that PCOS may be due to an emotional "sweetness" because of the person’s lack of love or his/her low intrapersonal intelligence.Increased insulin in the blood stimulates. Androgen secretion by the ovarian stroma the connective tissue of the Ovary & reduces serum sex Hormone binding globulin (SHBG) causing increased level of free testosterone. Due to presence of increased androgen in the ovary the follicle undergoing maturation in the ovarian cycle is affected causing anovulation of that particular follicle.so Cap Saptarangi effective in PCOS |