| CTRI Number |
CTRI/2023/06/053433 [Registered on: 02/06/2023] Trial Registered Prospectively |
| Last Modified On: |
01/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see effect of panchakarma and shatapushpa churna in Polycystic ovarian Diseases. |
|
Scientific Title of Study
|
A clinical trial to evaluate the efficacy of Shatapushpa churna following Vaman karma and following Basti karma in Artavakshaya w.s.r to Polycystic ovarian diseases |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JSAM/IECHR/149/04-9-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishali Dave |
| Designation |
Associate professor |
| Affiliation |
JS Ayurveda Mahavidyalaya |
| Address |
Department of Prasutitantra evam striroga, JS Ayurved Mahavidyalay
College road , yogiraj society
Kheda
GUJARAT
387001
India |
| Phone |
09662140078 |
| Fax |
|
| Email |
vaishalivasavda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishali Dave |
| Designation |
Assistant professor |
| Affiliation |
JS Ayurveda Mahavidyalaya |
| Address |
Department of Prasutitantra evam striroga,JS Ayurved Mahavidyalay
College road , yogiraj society
Kheda
GUJARAT
387001
India |
| Phone |
09662140078 |
| Fax |
|
| Email |
vaishalivasavda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Dave |
| Designation |
Assistant professor |
| Affiliation |
JS Ayurveda Mahavidyalaya |
| Address |
Department of Prasutitantra evam striroga,JS Ayurved Mahavidyalay
College road , yogiraj society
Kheda
GUJARAT
387001
India |
| Phone |
09662140078 |
| Fax |
|
| Email |
vaishalivasavda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sundar Ayurveda Pharmacy, Nadiad |
|
|
Primary Sponsor
|
| Name |
JS Ayurveda Mahavidyalaya |
| Address |
JS Ayurveda Mahavidyalaya
College road Nadiad
387001 |
| Type of Sponsor |
Private 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 |
| Vaishali Dave |
JS Ayurveda Mahavidyalaya |
Room no 132, PTSR OPD, PD Patel Ayurveda HOspital.
JS Ayurved Mahavidyalay
College road , yogiraj society
Kheda
GUJARAT |
09662140078
9662140078
vaishalivasavda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JS Ayurveda Mahavidyalaya INSTITUTIONAL ETHICS COMMITTEE for human research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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 | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Procedure Reference: Procedure Reference: Vruddha jeevaka vidyotini Hindi tika Kashyapa Samhita writtern by Nepalrajguru Hemarajsharma Chaukhamba Sanskrit Sansthan Varanasi, reprinted- 2010 Siddhi 7th chepter verse 11th Pp – 364, Procedure details: Procedure details: Procedure details: Procedure details: Yoga Basti Anuvasana basti : Shatpushpa taila Niruha basti : Shatpushpa quath 250 and kalka 15gm, honey 30ml, Go-mutra 15 ml, yava kshara 5 gm or saindhava 5gm,Ushakadi gana fine powder 5gm Poorva karma: Abhyanga : Narayana taila Bashpasweda : Nirgundi patra Anuvasana basti: 40 ml Niruha basti: 320 ml Total: 8 days))
(1) Medicine Name: Shatpushpa churna, Reference: Kashyap samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 52 Days | | 2 | Comparator Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-करà¥à¤®/ पà¥à¤°à¤šà¥à¤›à¤°à¥à¤¦à¤¨à¤®à¥ | (Procedure Reference: (Procedure Reference: 5) Shri Dalhanacharya Sushruta Samhita nibandha sangraha commentary by Sushruta. edited by vaidya yadavji Trikamji Acharya Chaukhamba Sanskrit Sansthan Varanasi, reprinted - 2012 Sutrasthan 15th chepter Verse- 12 Pp – 824.,, Procedure details: Procedure details: Deepana, Pachana, Snehana bahya and abhyantara, Vaman karma, Samsrjana karma)
)
(1) Medicine Name: Shatpushpa churna , Reference: Shri Dalhanacharya Sushruta Samhita nibandha sangraha commentary by Sushruta. edited by vaidya yadavji Trikamji Acharya Chaukhamba Sanskrit Sansthan Varanasi, reprinted - 2012 Sutrasthan 15th chepter Verse- 12 Pp – 824.,, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Duration: 52 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1) Patients diagnosed with Artava Kshaya.
2) Patients diagnosed with PCOD
3) Patients fit for Vamana karma or Basti karma.
|
|
| ExclusionCriteria |
| Details |
1) Patients suffering from Artavakshaya secondary to hypo/hyper thyroidisim, tuberculosis, anemia, congenital adrenal hyperplasia, androgen secreting tumors, functional hypothalamic amenorrhoea, hyperprolactinaemia, any congenital deformity in genital tract.
• Patients with cardiac disorders, congenital anomalies of reproductive organs, malignant tumours of reproductive organs, adrenal/pituitary tumours, Cushing Syndrome..
• Patients associated with any other severe systemic illness.
|
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| patient will get normal menstrual cycle ,Normal ovarian volume and normal follicular growth will be assessed through sonography |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| patients normal mentrual cycle normal follicular growth & normal ovarian volume will be maintained |
8weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 |
|
Date of First Enrollment (India)
|
14/06/2023 |
| 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="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
- |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - None of the above
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vaishalivasavda@gmail.com].
- For how long will this data be available start date provided 02-01-2023 and end date provided 31-01-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
An increasing number of patients with various forms of menstrual irregularities are seen. Prevalence of PCOD in India ranges from 3.7 to 22.5 per cent depending on the population studied and the criteria used for diagnosis1.Of the various lines of treatment available for PCOD, hormonal therapy is the main choice. Hormone therapy may provide excellent results for a short period. But over time it can lead to irreversible metabolic damage. It further depletes the already taxed endocrinal system and puts it to sleep.2 There is no clear correlation of PCOD in Ayurveda classics, but based on symptoms In artavakshaya menstruation fails to occur at proper time i.e regular monthly cycles do not occur or cycles are delayed or scanty3. Hence based on the symptoms artavakshaya can be correlated with Polycystic ovarian disease. In samprapti main doshik involvement in PCOD is Vata and Kapha. In Ayurveda classics samshodhana and agneya substances are advised as main line of treatment.4 Hence vamana karma is advised as samshodhana karma as it removes saumya (Kapha) substances causing relative increase in agneya constituents and as a consequence increase artava5. Apaana Vayu is the governing factor of the normal physiology of menstruation5. If there is any obstruction in the prakruta movement of apaana vayu, it gets vitiated and affects artava pravritti. In this aspect, Basti chikitsa is considered to be the best treatment6.The drug Shatapushpa is also indicated for any type of artava kshaya i.e qualitative , quantitative or frequency.7 Hence in the present study, an attempt is made to compare the effect of Vamana Karma and Basti and Shatapushpa choorna in the management of Artavakshaya w.s.r. to PCOD (Polycystic Ovarain disease). |