| CTRI Number |
CTRI/2022/10/046150 [Registered on: 04/10/2022] Trial Registered Prospectively |
| Last Modified On: |
02/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study of narayana taila nasya in no menses, painful menses, infrequent menses |
|
Scientific Title of Study
|
Clinical study of narayana taila nasya in vataj artava dusti |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Stuti Rawat |
| Designation |
PG scholar |
| Affiliation |
Gurukul campus Haridwar |
| Address |
Department of Panchakarma
OPD no. 24
Gurukul campus
Haridwar
U.A.U
Hardwar
UTTARANCHAL
249404
India |
| Phone |
09058966236 |
| Fax |
|
| Email |
stu1593@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uttam Kumar Sharma |
| Designation |
Professor |
| Affiliation |
Gurukul campus Haridwar |
| Address |
Department of Panchakarma
OPD no. 24
Gurukul campus
Haridwar
U.A.U
Hardwar
UTTARANCHAL
249404
India |
| Phone |
7017684300 |
| Fax |
|
| Email |
druksm27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Stuti Rawat |
| Designation |
PG scholar |
| Affiliation |
Gurukul campus Haridwar |
| Address |
Department of Panchakarma
OPD no. 24
Gurukul campus
Haridwar
U.A.U
Hardwar
UTTARANCHAL
249404
India |
| Phone |
09058966236 |
| Fax |
|
| Email |
stu1593@gmail.com |
|
|
Source of Monetary or Material Support
|
| UAU, Gurukul Campus, Haridwar, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
Department of Panchakarma Gurukul campus UAU Haridwar |
| Address |
Department of Panchakarma
OPD no. 24
Gurukul campus
UAU Haridwar |
| 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 Stuti Rawat |
Gurukul Ayurvedic College , Haridwar |
Department of Panchakarma
OPD no. 24
Gurukul Ayurvedic College
Haridwar
U.A.U
Hardwar
UTTARANCHAL |
09058966236
stu1593@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E35||Disorders of endocrine glands in diseases classified elsewhere. Ayurveda Condition: VATAJA-ARTAVADUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Narayana taila, Reference: Sharangdhar samhita madhyama khanda chapter 9, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 16(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Medicine will be given in alternate days for 10 days then 5 days break will be given and again medicine will be administered for 10 every alternate days. |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients with signs and symptoms of vataj artava dusti such as vikrit artava varna, ruja and artava which is ruksh, tanu, fenil, alpa, vichinna and vilambit.
2.Patients with polycystic ovaries.
3.Patients having altered FSH/LH.
4.Patients with oligomenorrhoea, dysmenorrhoea, hypomenorrhea and amenorrhoea.
|
|
| ExclusionCriteria |
| Details |
1.Patients with haemoglobin less than 7 g/dl.
2.Patients with psychiatric disorders, epilepsy, heart disease, etc
3.Patients with known cases who are immunocompromised like HIV etc; who have haematological disorders such as haemophilia, leukemia etc.
4.Patients with uncontrolled DM, HTN, Hypothyroidism.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of assessment on basis of parameters like-
Artava varna (Colour), Artava pramana, Ruja (Pain), Rajaha sarava avidhi (Duration of menses), tanu, vilambit, vichinna artava.
Fenil artava
tanu, vilambit, vichinna artava.
|
1 day and 45 day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•CBC
•Hb%
•Thyroid profile
•USG- abdomen and pelvis
•FSH, LH
•Serum Estradiol
•Serum Progesterone
•Serum Prolactin
•Serum Testosterone
•AMH
|
1 day and 45 day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/10/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinical study of Narayana Taila Nasya in Vataj Artava Dusti. |