| CTRI Number |
CTRI/2024/10/075955 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
03/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the effect of Shatavari Taila Prathimarsha Nasya and Lasunadi Vati in the treatment of Irregular Menstruation |
|
Scientific Title of Study
|
Clinical study On the Combined effect of Shatavari Taila Prathimarsha Nasya and Lasunadi vati in the management of Arthava kshaya(Oligo-Hypomenorrhoea) |
| 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 Anjana khannur |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala
Manjunatheshwara College of Ayurveda and Hospital, B M road,
Thanniruhalla, Hassan, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
7204139929 |
| Fax |
|
| Email |
Anjanakhannur100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathima |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala
Manjunatheshwara College of Ayurveda and Hospital, B M road,
Thanniruhalla, Hassan, Karnataka, India
Hassan
KARNATAKA
573201
India |
| Phone |
9611990497 |
| Fax |
|
| Email |
drprathima@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathima |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga, Sri Dharmasthala
Manjunatheshwara College of Ayurveda and Hospital, B M road,
Thanniruhalla, Hassan, Karnataka, India
KARNATAKA
573201
India |
| Phone |
9611990497 |
| Fax |
|
| Email |
drprathima@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla, Hassan, Karnataka,PIN-573201 India
Phone No-08172256460,
E-mail -sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and
Hospital, BM road, Thanniruhalla, Hassan, Karnataka, Pin-573201,
India Phone No-08172256460, E-mail - sdmcah@gmail.com
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Anjana |
Shri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, B M road, Thanniruhalla |
Department of Prasuti
tantra and Stree roga,
OPD NO 20
Hassan
KARNATAKA |
7204139929
Anjanakhannur100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N948||Other specified conditions associated with female genital organs and menstrual cycle. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Kashyapa samhita, Procedure details: Shatavari taila prathimarsha nasya 2 drops in each nostril twice a day)
(1) Medicine Name: Shatavari taila, Reference: Kashyapa sahmita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Duration: 2 Months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: LASHUNADI VATI, Reference: VAIDYA JEEVANA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -HOT WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Subject with age group 18-35years
2 .Subject with interval of menstruation 35-60days
3.Subjects who are fulfilling the diagnostic criteria
4.Subjects with or without PCOS.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women
2.Subjects on OCPs, IUCD
3.Subject with diagnosed cases of congenital anamolies in female genital tract
4.Subjects with diagnosed case of fibroid uterus,benign and malignant tumors of reproductive organs.
5.known case of diabetes mellitus, hypertension
6.subjects positive for HbsAg, HIV,VDRL
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major symptoms like irregular menstruation, scanty bleeding should be corrected |
6TH AND 8TH WEEK |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other symptom like pain during menstruation should also be reduce |
3 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/11/2024 |
| 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
|
This study is an open labelled single arm clinical trial to evaluate the combined effect of shatavari taila prathimarsha nasya and lashunadi vati in 30 patients with arthava kshaya(oligo-hypomenorrhoea). the study will be conducted at out patient department of prasuti tantra and stree roga in sri dharmastala manjunatheshwara ayurveda hospital,hassan, karnataka. patient will be advised to put 2 drops of shatavari taila in each nostril twice day before food after complete cessation menstruation for two menstrual cycle and lashunadi vati 500mg thrice a day before food for 7 days for 2 menstrual cycle and assessment will be done at baseline, follow up on third menstrual cycle |