| CTRI Number |
CTRI/2024/11/077006 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Chitrakagrandhikadi kashaya in inducing menstrual bleeding in participants with delayed periods for more than 35 days.
|
|
Scientific Title of Study
|
Effect of Chitrakagrandhikadi kashaya in inducing menstrual bleeding in Nashtartava.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aiswarya R |
| Designation |
PG Scholar |
| Affiliation |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY |
| Address |
DEPARTMENT OF PRASUTITANTRA EVAM STREE ROGA PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY SHORANUR THRISSUR KERALA
Thrissur
KERALA
679531
India |
| Phone |
09944454460 |
| Fax |
|
| Email |
aisunathan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Salini P |
| Designation |
Professor and HOD |
| Affiliation |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY |
| Address |
DEPARTMENT OF PRASUTITANTRA EVAM STREE ROGA PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY SHORANUR THRISSUR KERALA
Thrissur
KERALA
679531
India |
| Phone |
7025130539 |
| Fax |
|
| Email |
salipkavungal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aiswarya R |
| Designation |
PG Scholar |
| Affiliation |
PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL, CHERUTHURUTHY |
| Address |
DEPARTMENT OF PRASUTITANTRA EVAM STREE ROGA PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL CHERUTHURUTHY SHORANUR THRISSUR KERALA
Thrissur
KERALA
679531
India |
| Phone |
09944454460 |
| Fax |
|
| Email |
aisunathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| PNNM Ayurveda medical college and hospital Cheruthuruthy Shoranur Thrissur INDIA 679531 |
|
|
Primary Sponsor
|
| Name |
Aiswarya R |
| Address |
PNNM Ayurveda medical college and hospital Cheruthuruthy Shoranur Thrissur INDIA 679531 |
| 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 Salini P |
P.N.N.M Ayurveda medical college and hospital |
DEPARTMENT OF PRASUTITANTRA EVAM STREE ROGA PNNM Ayurveda medical college and hospital Cheruthuruthy Shoranur Thrissur KERALA
Thrissur
KERALA |
7025130539
salipkavungal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PNNM AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
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 | Drug | Classical | | (1) Medicine Name: CHITRAKAGRANDHIKADI KASHAYA, Reference: ASHTANGAHRIDAYAM CHIKITSASTHANAM, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -JALAM HINGU), Additional Information: MEDICINE SHOULD BE ADMINISTERED TILL THE ONSET OF MENSTRUATION OR UPTO 7 DAYS |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Women with absence of menstruation for more than 35 days.
Cases with endometrial thickness greater than 6mm. |
|
| ExclusionCriteria |
| Details |
Patients trying for conception.
Pregnant women.
Postnatal and lactating women.
Patient with acid peptic diseases.
Cases of primary amenorrhea
Haemoglobin level less than 7 gm%
Concurrent medication for other systemic and chronic illnesses.
K/c/o Bleeding disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Attaining menstrual bleeding in Nastartava |
Upto day 10 after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Getting menstrual bleeding in subjects having delayed periods more than 35 days. |
Upto 10 days after intervention. |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
29/11/2024 |
| 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="0"
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 to evaluate the effect of formulation mentioned in the gulma chikitsa of Astangahridayam, chikitsastanam, in inducing menstrual bleeding in Nastartava. Hypothesis of the study is, Chitrakagrandikadi kashaya is effective/ not effective in indicing menstrual bleeding in Nastartava. |