| CTRI Number |
CTRI/2023/06/053524 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
04/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation Of The Efficacy Of Shatapushpa Taila Nasya In The Management Of Artava Kshaya |
|
Scientific Title of Study
|
Evaluation of the efficacy of shatapushpa taila nasya in the management of artava kshaya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anudeepa Nath |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurvedic College and Hospital Jalukbari Guwahati Assam 781014 |
| Address |
Department Of Prasuti Tantra Avum Stree Roga Government Ayurvedic College And Hospital Jalukbari Guwahati Assam 781014
Kamrup
ASSAM
781014
India
Kamrup
ASSAM
781014
India |
| Phone |
8638250548 |
| Fax |
|
| Email |
anudeepa.cpm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipak Kumar Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Govt Ayurvedic College And Hospital |
| Address |
Department Of Prasuti Tantra Avum Stree Roga Govt. Ayurvedic College And Hospital Jalukbari Guwahati Assam 781014
Kamrup
ASSAM
781014
India |
| Phone |
8486324789 |
| Fax |
|
| Email |
dr.dkgoswami@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipak Kumar Goswami |
| Designation |
Assistant Professor |
| Affiliation |
Govt Ayurvedic College And Hospital |
| Address |
Department Of Prasuti Tantra Avum Stree Roga Govt. Ayurvedic College And Hospital Jalukbari Guwahati Assam 781014
Kamrup
ASSAM
781014
India |
| Phone |
8486324789 |
| Fax |
|
| Email |
dr.dkgoswami@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College And Hospital Jalukbari Guwahati Assam 781014 |
|
|
Primary Sponsor
|
| Name |
DR ANUDEEPA NATH |
| Address |
GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL JALUKBARI GUWAHATI ASSAM 781014 |
| 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 Dipak Kumar Goswami |
Govt Ayurvedic College And Hospital Jalukbari Guwahati Assam 781014 |
Opd And Ipd Of Prasuti Tantra Avum Stree Roga Department Government Ayurvedic College And Hospital Jalukbari Guwahati Assam 781014
Kamrup
ASSAM |
8486324789
dr.dkgoswami@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL JALUKBARI GUWAHATI ASSAM 781014 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nAvanam, नावनमॠ| (Procedure Reference: Sharangdhar Samhita Uttara khanda 8/8, 38-56, Procedure details: Poorvakarma- 1.Sthanik abhyanga with tila taila
2. Vaspa swedana
Pradhana karma- Shatapushpa taila - 6 drops in each nostril for 7 days ( starting from 5th day of menses upto 11th day ) each in 3 consecutive cycles.
Paschyat karma- Hot water gargling , Massaging of palm soul and shoulder , Dhumpana)
(1) Medicine Name: Shatapushpa Taila, Reference: Kashyap Samhita Chikitsa Sthana 18/21-28, Route: Nasal, Dosage Form: Taila, Dose: 6(drops), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Infrequent Menses At Interval Between Two Cycle Exceeding More Than 35 Days
2. Reduced Quantity Of Flow That Is Using Less Than 2 Pads Per Day
3.Artava Kshaya Due To PCOD
4.Duration Of Flow Less Than Two Days
5.Irrespective Of Marriage
|
|
| ExclusionCriteria |
| Details |
Pregnant Women
Lactating Women
Patient Having Systemic Disorders
Hyperthyroidism
Severe Anaemia hb level Less Than 7Gm/Dl
Any Type Of Malignancy. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decrease In Symptoms Of Artava Kshaya Like
Normalise The Interval Between Two Cycles
To Normalise The Amount Of Blood Loss
To Normalise The Duration Of Bleeding
MInimise The Grade Of Pain |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ultrasonography of lower abdomen to be within normal limit
TSH T3 T4
Serum prolactin
Haemoglobin |
90 Days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/06/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THIS IS AN EFFECTIVENESS OF SHATAPUSHPA TAILA IN THE FORM OF NASYA IN THE MANAGEMENT OF ARTAVA KSHAYA . THIS IS DONE COMPULSORY PART OF POST GRADUATE COURSE. TOTAL NUMBER OF PATIENTS TO BE STUDIED IS 30 WITH DURATION OF 30 DAYS. |