| CTRI Number |
CTRI/2024/01/061912 [Registered on: 29/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Narayana Tail Treatment In Polycystic Ovarian Syndrome |
|
Scientific Title of Study
|
A clinical study to evaluate the efficacy of Narayana Taila Nasya and Matra Basti on Pushpaghani Jataharini with special reference to Poly Cystic Ovarian Syndrome. |
| Trial Acronym |
Narayana Taila Nasya and Matra Basti on Pushpaghani Jataharini with special reference to Poly Cystic Ovarian Syndrome. |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheela Verma |
| Designation |
MS Scholar |
| Affiliation |
Government Ayurvedic PG College And Hospital Varanasi |
| Address |
Department Of Prasuti Tantra Evum Stri Roga Government Ayurvedic PG College And Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
|
| Fax |
|
| Email |
ms.sheelaverma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Anjana saxena |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic PG College And Hospital Varanasi |
| Address |
Department of Prasuti Tantra Evum Stri Roga Government Ayurvedic PG College And Hospital
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9839041045 |
| Fax |
|
| Email |
saxenadranjana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheela Verma |
| Designation |
MS Scholar |
| Affiliation |
Government Ayurvedic PG College And Hospital Varanasi |
| Address |
Department of Prasuti Tantra Evum Stri Roga Government Ayurvedic PG College And Hospital Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
63946490028 |
| Fax |
|
| Email |
ms.sheelaverma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment Ayurvedic PG College And Hospital Varanasi |
|
|
Primary Sponsor
|
| Name |
Goverment Ayurvedic PG College |
| Address |
Department Of Prasuti Tantra Evum Stri Roga Goverment Ayurvedic PG College And Hospital Varanasi |
| Type of Sponsor |
Government 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 Sheela Verma |
Government Ayurvedic PG College And Hospital Varanasi |
Department Of Prasuti Tantra Evum Stri Roga
Varanasi
UTTAR PRADESH |
6394649028
ms.sheelaverma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurvedic PG College And Hospital Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: Pushpaghani jataharini, (2) ICD-10 Condition:N948||Other specified conditions associated with female genital organs and menstrual cycle. Ayurveda Condition: ARTAVADOSHAH/ARTAVADUSHTIH/RAJODOSHAH, (3) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Matra Basti | (Procedure Reference: Sharangdher Samhita, Procedure details: Matra Basti )
(1) Medicine Name: Narayana Tail , Reference: Sharangdher Samhita , Route: Topical, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Married And Unmarried Both
Reproductive age group of 20-35years
BMI Between 18-25 kg/meter square
>11 Hb gm% |
|
| ExclusionCriteria |
| Details |
Patient not willing for trail
Patient with excess androgen
Patient having Thyroid problem
Diabetic patient
Cardiovascular patient
Tuberculosis patient |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe rate of ovulatory cycle |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve anovulatory cycle |
90days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
05/02/2024 |
| Date of Study Completion (India) |
27/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
International Research Journal of Ayurveda & Yoga- Ayurvedic Approach to PCOS-A Critical Review
World Journal of Pharmaceutical Research- A CLINICAL STUDY OF MATRA BASTI AND YONI BASTI WITH
NARAYANA TAILA INPUSHPAGHANI JATAHARINI W. S. R. TO
PCOS
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
A Clinical Study Of Evaluate Efficacy Of Narayan Tail Nasya and Matra Basti On Pushpaghani Jataharini WSR to PCOS Total 100 patient are divided in to 2group unmarried and married group. Group A 50 unmarried patient will be treated with Nasya and Matra Basti. Group B 50 married patient will be treated with nasya and Matra Basti |