| CTRI Number |
CTRI/2024/09/073661 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating the effect of Jeeraka Avaleha in patients with Raktapradara and compare its efficacy with Pushyanuga Churna |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the Efficacy of Jeeraka Avaleha in Raktapradara
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saniya Mahammedsab Sanadi |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Moodubidire |
| Address |
Department of P.G Studies in Prasuti Tantra Evam Stree Roga, Alvas Ayurveda Medical College and Hospital Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8217896126 |
| Fax |
|
| Email |
saniyasanadi@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kavitha B K |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Moodubidire |
| Address |
Department of P.G Studies in Prasuti Tantra Evam Stree Roga, Alvas Ayurveda Medical College and Hospital Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9008979169 |
| Fax |
|
| Email |
drkavithapradeep@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saniya Mahammedsab Sanadi |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College and Hospital Moodubidire |
| Address |
Department of P.G Studies in Prasuti Tantra Evam Stree Roga, Alvas Ayurveda Medical College and Hospital Moodubidire
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
8217896126 |
| Fax |
|
| Email |
saniyasanadi@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical College and Hospital Moodubidire, Dakshina Kannada, Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Dr Saniya Mahammedsab Sanadi |
| Address |
Department of P.G Studies in Prasuti Tantra Evam Stree Roga, Alvas Ayurveda Medical College and Hospital Moodubidire, Dakshina Kannada, Karnataka 574227 |
| 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 Saniya Mahammedsab Sanadi |
Alvas Ayurveda Medical College and Hospital Moodubidire |
Department of P.G Studies in Prasuti Tantra Evam Stree Roga, Alvas Ayurveda Medical College and Hospital Moodubidire, Dakshina Kannada, Karnataka 574227
Dakshina Kannada
KARNATAKA |
08217896126
saniyasanadi@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Alvas Ayurveda Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N921||Excessive and frequent menstruation with irregular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pushyanuga Churna, Reference: Charak Samhita Chikitsa Stana, Chapter 30 Yonivyapadchikitsa, Shloka no 90-95 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: Yes(details: Madhu (Sahapana) and Tandulodaka), Additional Information: Drug is administered from 4th day of menstrual cycle for 8 days for 2 consecutive cycles | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jeeraka Avaleha, Reference: Yogatarangini of Trimalla Bhatta, Chapter 74 Pradara, Shloka no 3-6 , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 24(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: Yes(details: 150ml Ksheera/ Sukoshna Jala), Additional Information: Drug is administered from 4th day of menstrual cycle for 8 days for 2 consecutive cycles. |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1)Patients fulfilling diagnostic criteria
2)Patients will be selected in the age group of 15 to 45 years.
3)Patient with Hb more than 8-gram percent
4)Both married and unmarried women
5)Patient having excessive bleeding/prolonged bleeding/intermenstrual bleeding with the history of minimum of 2 cycles.
|
|
| ExclusionCriteria |
| Details |
1)Patient with the history of bleeding disorders, DM, HTN, TB.
2)Endocrinal disorders like Thyroid Dysfunction, PCOS.
3)IUCD, OCP
4)Any benign or malignant growth in reproductive tract.
5)PID, Endometriosis, Adenomyosis, Uterine Fibroids, Uterine polyp.
6)If any Anatomical defects.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The effect of treatment will be assessed on the
basis of subjective criteria
1.Anruthau Alpam Api- Intermenstrual Scanty Bleeding
2.Vedana – Pain
objective criteria
1) Duration of menstrual flow
2) Amount of menstrual flow (Pictorial blood loss assessment)
3) Interval between cycles |
Assessment will be done on 4th day, 7th day and 11th day of the cycle during the period of treatment for 2 consecutive cycles. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
after treatment assessment will be done on the
basis of
a) subjective criteria:
i)Intermenstrual Bleeding
ii)Pain during menstruation
b) Objective Criteria-
i)Duration of menstrual flow
ii)Amount of menstrual flow (Pictorial blood loss assessment)
iii)Interval between cycles |
After treatment assessment will be done on 4th day of 3rd cycle. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/10/2024 |
| 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="2"
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
|
Among the gynecological disorders, Raktapradara is frequent complaint
and the incidence has become
higher with degree of civilization. If this condition is not treated, it will lead to complications like infertility, anemia,
endometrial malignancy. According
to modern, hormonal methods are the first line in medical management.
Unfortunately, many options can be
associated with hormonal side effects, prevention of fertility and lack of
efficacy, leading to discontinuation and progression to
surgical interventions. Thus, to
avoid it Jeeraka Avaleha in
Yogatarangini, Pradara Adhyaya has
been mentioned as excellent medicine in Raktapradara It has drugs which
contain Stambana, Artavajanana, Shulahara, Angamarda Prashamana, Pandugna
etc properties. It also has the drugs whose phytochemicals show anti-inflammatory, anti-oxidant, analgesic, antispasmodic action and can also be easily
palatable. therefore an attempt is made to study the clinical evaluation of Jeeraka Avaleha in the management of raktapradara and compare its efficacy with the Pushyanuga choorna.
|