| CTRI Number |
CTRI/2023/07/055258 [Registered on: 16/07/2023] Trial Registered Prospectively |
| Last Modified On: |
14/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparative study of shatapushpa taila nasya & shatapushpa churna in artavakshya |
|
Scientific Title of Study
|
comparative efficacy of shatapushpa taila nasya & shatapushpa churna in artavakshaya |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Lalita Prajapat |
| Designation |
MS Scholar |
| Affiliation |
Banaras Hindu University Varanasi ,Uttar Pradesh 221005 india |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi ,Uttar Pradesh 221005 india
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi ,Uttar Pradesh 221005 india
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8619747311 |
| Fax |
|
| Email |
drlalita015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof dr Deepa Mishra |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University Varanasi ,Uttar Pradesh 221005 india |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi ,Uttar Pradesh 221005 india
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi ,Uttar Pradesh 221005 india
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650453095 |
| Fax |
|
| Email |
deepa1971mishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof dr Deepa Mishra |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University Varanasi Uttar Pradesh |
| Address |
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi ,Uttar Pradesh 221005 india
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi ,Uttar Pradesh 221005 india
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650453095 |
| Fax |
|
| Email |
deepa1971mishra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital Faculty of Ayurveda Varanasi Uttar Predesh |
|
|
Primary Sponsor
|
| Name |
Dr Lalita Prajapat |
| Address |
Depatment of Prasuti Tantra Faculty if Ayurveda Institute of Medical Science Banaras Hindu University uttar predesh |
| 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 Lalita Prajapat |
Opd no 24. Sir Sunderlal Hospital Varanasi uttar pradesh |
Department of Prasuti Tantra Faculty of Ayurveda Institute of Medical Science sir Sunderland hospital uttar pradesh
Varanasi
UTTAR PRADESH |
8619747311
drlalita015@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:E663||Overweight. Ayurveda Condition: Hypo-oligomenorrhea, (2) ICD-10 Condition:E282||Polycystic ovarian syndrome. Ayurveda Condition: Hypo-oligomenorrhea, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shatpushpa churna shatpushpa tail, Reference: kashyapsamhita khil sthan, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: milk), Additional Information: -shatpushpa taila Nasya 8drop each nostril |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Age group 18- 40 yrs.
Interval between two menstrual cycles is greater than 35 days. (for the last 6 months approximately)
The duration of menstrual flow is 2 days or less. .(for the last 6 months approximately)
The quantity of menses is less than 20 ml.
Poly Cystic Ovarian Disease (PCOD) with the symptom of oligomenorrhea and hypomenorrhea.
|
|
| ExclusionCriteria |
| Details |
Patients below the age of 18 years and above the age of 40 years.
Positive history of venereal diseases (HIV, HBsAg, Anti HCV, VDRL, HPV, Genital herpes, etc.)
Pregnant women, lactating mothers.
Poly Cystic Ovarian Disease (PCOD) with menorrhagia.
Patient having organic pathology of uterus & adnexa like cervical carcinoma or any malignant growth.
Patients will not give consent to participate in the study.
Patients using oral contraceptive pills.
Patients who cannot attend follow-up regularly. Who is participating in another study.
Women suffering from Nasal polyp, D.N.S.(Deviated nasal septum), Rhinitis. Nasal tumor, and history of nasal surgery previous.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Regular Menstrual Cycle Improvement of quality of life
|
Every 4weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Interval between two cycles (intermenstrual period/Duration between two Artava darshana)
2.Amount of menstrual flow (Artava strava pramana )
3.Pain during menses (Yoni vedana)
Quality of life
|
90days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
28/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/07/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In the present scenario menstrual disorder is the commonest gynecological problem in females of the reproductive age group. On account of the disturbance in intake of proper diet and rest, stress, and strain with the change of lifestyle, menstrual disorders have become a very challenging problem for working women or housewives. They may involve structural or functional disturbances and are mostly associated with the complaint of infertility, psychological problems, obesity, etc. Nowadays in modern science scanty (Hypomenorrhea) and infrequent menstruation (oligomenorrhea) are treated by hormonal therapy and long-term use of these drugs may produce many side effects. Artavakshaya may be correlated with oligomenorrhea and hypomenorrhea. In the Ayurvedic classic various Shamana and Shodhana drugs are described for Artavakshaya. Ayurvedic medicines cure Artavakshaya by improving agni and remove of Shrotorodha by using these potent Ayurvedic medicines. Side effects of the allopathic treatment can be avoided. Single-drug therapy can be taken easily by females during their busy schedules. Therefore, the present study is undertaken to evaluate and compare the effect of Shatapushpa Taila Nasya and Shatapushpa Churna in the management of Artavakshaya. |