| CTRI Number |
CTRI/2022/04/042198 [Registered on: 27/04/2022] Trial Registered Prospectively |
| Last Modified On: |
25/04/2022 |
| 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
|
Clinical trial Of Ashoka Valkala Granules in Puberty Menorrhagia |
|
Scientific Title of Study
|
A randomised open prospective controlled clinical trial of Ashoka Valkala Granules in Asrugdar W.S.R to Puberty Menorrhagia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amruta Suresh Dhulubulu |
| Designation |
PG Scholar |
| Affiliation |
Yashwant ayurvedic college |
| Address |
Yashwant Ayurvedic college, post graduate training and research centre,Kodoli, TAL:Panhala,DIST:Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8080450242 |
| Fax |
|
| Email |
amrutadhulubulu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishala Turlapati |
| Designation |
Professor, MD, PhD, Prasutitantra evum striroga |
| Affiliation |
Yashwant ayurvedic college kodoli |
| Address |
Yashwant Ayurvedic College,Strirog Prasutitantra Department,OPD
no-8 Kodoli, Tal.Panhala,Dist.Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9960217429 |
| Fax |
|
| Email |
vishalaturlapati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amruta Suresh Dhulubulu |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College Kodoli |
| Address |
Yashwant Ayurvedic college, post graduate training and research centre,Kodoli, TAL:Panhala,DIST:Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8080450242 |
| Fax |
|
| Email |
amrutadhulubulu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic college, Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Amruta Suresh Dhulubulu |
| Address |
Yashwant Ayurvedic Hospital Kodoli Kolhapur |
| 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 Amruta Suresh Dhulubulu |
OPD no. 8 Striroga Prasutitantra Department |
Yashwant Ayurved college , kodoli, tal- panhala
Kolhapur
MAHARASHTRA |
8080450242
amrutadhulubulu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N922||Excessive menstruation at puberty. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Desogestrel 0.15mg & Ethinyloestradiol 0.02mg | Desogestrel 0.15mg & Ethinyloestradiol
0.02mg
1 Tab. OD after bleeding stops (from 5th day to 25th day of
each cycle)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ASHOKA VALKALA KSHEERPAK, Reference: YOGARATNAKAR, Route: Oral, Dosage Form: Khanda /Granules, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 4 Months, anupAna/sahapAna: Yes(details: Dugdha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
19.00 Year(s) |
| Gender |
Female |
| Details |
1.Age – 13-19 years unmarried girls.
2.Patients with irregular or prolonged cycle & excessive bleeding per vagina during Menstruation
3.Polymenorrhagia.
4.Intermenstrual bleeding (Anruta Artava-Chakradatta )
5.Patients with Vataj asrugdar lakshna’s.
|
|
| ExclusionCriteria |
| Details |
K/H/O Endocrinal Disorder like Hypo or Hyperthyroidism, PCOS .
2. K/H/O Bleeding Dyscrasias
3. K/H/O Structural Abnormality in Genital Organ.
4.Married Female.
6.Juvenile DM.
7.Patients with Pittaj and Kaphaj asrugdar lakshna’s.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease the symptoms using ashoka valkala granules with cow milk in Asrugdar w.s.r to Puberty Menorrhagia |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To reduce duration & amount of bleeding.
2.To assess improvement by parameters like PBAC.
3.To study the etio-pathology of asrugdar & puberty menorrhagia in detail.
4.To achieve the out-come of study in 120 days.
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
01/05/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomised open prospective controlled clinical trial of ashoka valkala granules in asrugdar w.s.r. to puberty menorrhagia. Study will be carried in OPD of Striroga Department of Yashwant Ayurvedic College and Hospital, Kodoli |