| CTRI Number |
CTRI/2024/12/077940 [Registered on: 11/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Curative ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of selected ayurvedic treatment protocol in nashtarthava |
|
Scientific Title of Study
|
Effect of selected ayurvedic treatment protocol in nashtarthava |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Safeeda Nasrin BP |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Prasuti Evam Streeroga Department
Ground floor
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Prasuti Evam Streeroga Department
Ground floor
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9400513203 |
| Fax |
|
| Email |
safeedabp786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajitha R warriar |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda Medical College |
| Address |
Prasuti Evam Streeroga Department
Ground floor Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Prasuti Evam Streeroga Department
Ground floor
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9947144562 |
| Fax |
|
| Email |
drrajithawarriar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajitha R warriar |
| Designation |
Associate professor |
| Affiliation |
Government Ayurveda Medical College Dhanwantari Nagar Puthiyakavu Tripunithura Ernakulam |
| Address |
Prasuti Evam Streeroga Department
Ground floor
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Prasuti Evam Streeroga Department
Ground floor
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9947144562 |
| Fax |
|
| Email |
drrajithawarriar@gmail.com |
|
|
Source of Monetary or Material Support
|
| 1 Government Ayurveda Medical College Thripunithura Ernakulam 682301
India |
| Government Ayurveda Medical College
Thripunithura
Ernakulam
682301 |
|
|
Primary Sponsor
|
| Name |
Safeeda Nasrin BP |
| Address |
Government Ayurveda Medical College
Puthiyakavu
Tripunithura
682301 |
| 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 |
| Safeeda Nasrin BP |
Government Ayurveda Medical College |
Prasuti Evam Streeroga Department
Ground floor
Puthiyakavu
Thripunithura
Ernakulam Kerala
India
682301
Government Ayurveda Medical College
Dhanwantari Nagar
Puthiyakavu
Tripunithura
682301
Ernakulam
KERALA |
9400513203
safeedabp786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee for Ethics in Research (Institutional Review Board ), Government Ayurveda Medical College, Thripunithura,Kochi,Kerala/682301 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N911||Secondary amenorrhea. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
| | 2 | Intervention Arm | Procedure | - | Vicharana Snehapana | (Procedure Reference: Caraka, Procedure details: Subject will be given Vicharana Snehapana with Shatpala ghrita 10 ml bd with rice gruel for 7 days)
(1) Medicine Name: Shatpala ghrita , Reference: Ashtanga Hrudaya , Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Duration: 7 Days | | 3 | Intervention Arm | Procedure | - | | (Procedure Reference: , Procedure details: )
| | 4 | Intervention Arm | Procedure | - | Abhyanga | (Procedure Reference: Caraka, Procedure details: Abhyanga and ushna jala snana with tila taila for last 3 days of snehapana)
(1) Medicine Name: Tila taila, Reference: Caraka samhitha, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 3 Days | | 5 | Intervention Arm | Procedure | - | Sneha Virecana | (Procedure Reference: Caraka, Procedure details: Sneha Virecana with eranda taila in empty stomach on the 8 th day)
(1) Medicine Name: Eranda taila, Reference: Caraka, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: od, Duration: 1 Days | | 6 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Haritakyadi churna , Reference: Sharangadara Samhitha , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Lukewarm water ), Additional Information: Twice daily till menstruation or for a maximum of 45 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
The patient having absence of regular menstrual cycle for 3 months and more |
|
| ExclusionCriteria |
| Details |
Those who are pregnant or lactating
Those who are planning for pregnancy
Hb less than 8 gm%
Those who are currently on any hormonal medications or hormonal contraceptive
Known cases of uncontrolled diabetes and Hypertension
Known cases of genital malignancy
Known cases of chronic liver and renal disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of the selected Ayurvedic Treatment Protocol to induce menstruation in Nashtarthava |
Assessment will be done at baseline ,after 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of the selected Ayurvedic Treatment Protocol in Nashtarthava |
Assessment will be done at baseline ,after 4th,8th & 12 th |
|
|
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)
|
21/12/2024 |
| 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
|
The menstrual cycle forms a key role in the wellbeing of a women due to the changes in the lifestyle of the present-day world a lot of menstrual abnormalities are being encountered in OPDs of which the most important one is amenorrhea. Amenorrhea is the lack of menstruation in females between the ages of 12 and 49 who are reproductively active. They are divided into two categories: primary and secondary. Primary amenorrhea is when a young girl has not menstruated by 16 years of age. In women who have previously menstruated, Secondary amenorrhea is defined as the cessation of regular menses for six months or the equivalent of three previous cycle intervals, whichever is longer. Amenorrhea is a common challenge that gynecological practitioners face in OPDs. The prevalence of secondary amenorrhea is approximately 2% to 5%.
Nashtarthava is a condition that is described by Dalhana, either kapha or vata alone or kapha vata together may cause Avarana to arthava vaha srotas leading to Nashtarthava. Since the dosha vitiation and clinical features of Raktagulma and Nashtarthava are similar, therefore, Raktagulma treatment is chosen here to cure Nashtarthava. Raktagulma is another disorder that results in prolonged amenorrhea.
The aim of the study is to evaluate the effect of selected ayurvedic treatment protocol in Nashtarthava. The study design is interventional pre and post with a sample size of 30. Women aged 18-45 years attending Prasutitantra and Streeroga OPD, Govt Ayurveda College, Tripunithura, fulfilling inclusion and exclusion criteria will be selected for the study. Sampling method will be consecutive sampling. The subject will be given Vicharana snehapana with Shatpala ghrita 10ml BD with rice gruel for 7 days,whole body Abhyanga with tila taila and Ushna jala snana for the last three days of Snehapana.Then Sneha Virecana with Eranda taila in empty stomach on the 8th day. Followed by Haritakyadi churna 6gm BD with lukewarm water will be given thereafter, till the menstruation or for a maximum of 45 days.They are followed up for 90 days. Assessment will be done after each menstrual cycle till 90 days.
|