| CTRI Number |
CTRI/2023/06/053629 [Registered on: 07/06/2023] Trial Registered Prospectively |
| Last Modified On: |
06/06/2023 |
| 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
|
To Evaluate The
Effect of Laksha Choorna in Asridgara (Dysfunctional Uterine
Bleeding) |
|
Scientific Title of Study
|
“A Randomized Controlled Clinical Study To Evaluate the Effect of Laksha Choorna in Asrigdara (Dysfunctional Uterine Bleeding).†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr B Manisha Reddy |
| Designation |
PG scholar |
| Affiliation |
Shree Dharmasthala manjunatheswara institute of ayurveda and hospital |
| Address |
Shree Dharmasthala manjunatheswara institute of ayurveda and hospital bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9703353969 |
| Fax |
|
| Email |
bmanishareddy@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anusha M |
| Designation |
Associate professor |
| Affiliation |
Shree Dharmasthala manjunatheswara institute of ayurveda and hospital |
| Address |
Shree Dharmasthala manjunatheswara institute of ayurveda and hospital Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
8105777424 |
| Fax |
|
| Email |
dranusham@sdmayurbangalore.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Manisha Reddy |
| Designation |
PG scholar |
| Affiliation |
Shree Dharmasthala manjunatheswara institute of ayurveda and hospital |
| Address |
Shree Dharmasthala manjunatheswara institute of ayurveda and hospital Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9703353969 |
| Fax |
|
| Email |
bmanishareddy@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
| Shree Dharmasthala manjunatheswara institute of ayurveda and hospital bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr B Manisha Reddy |
| Address |
Shree Dharmasthala manjunatheswara institute of ayurveda and hospital bengaluru |
| 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 B Manisha Reddy |
SDM Ayurveda Hospital Bengaluru |
Shree Dharmasthala manjunatheswara institute of ayurveda and hospital bengaluru
Bangalore
KARNATAKA |
9703353969
bmanishareddy@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI DHARMASTHALA MANJUNATHESHWARA INSTITUTE OF AYURVEDA AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N938||Other specified abnormal uterine and vaginal bleeding. 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 choorna , Reference: caraka samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -tanduoldaka and madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: laksha choorna , Reference: cakradatta , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -goghrita ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1 Subjects presenting with pratyatma lakshanas of Asrigdara (Raja atipravruthi,DeerghaKalanubhandhi, Anruthavalpamapi) with Raja atipravruthi as a main symptom.
2. Ages for the study: 20-45years.
3. Subjects ready to sign the informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Participants who are not willing for trial.
2. Structural abnormalities involvement in uterus.
3. Uterine polyp.
4. Carcinoma of cervix.
5. Fibroid uterus.
6. Adenomyosis of the uterus.
7. Coagulation disorders like Haemophilia, Leukaemia, sickle cell anaemia.
8. Systemic diseases like Diabetes mellitus, Hypertension, epileptic disorders.
9. Haemoglobin less than 6 g/dL
10. Women using Intra Uterine contraceptive Devices or oral contraceptive pills.
11. Bleeding after menopause.
12. Miscarriages. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Amount & duration of bleeding |
fifth day of menstrual cycle for two consecutive menstrual cycles
Observational
Followup fifth day of third Menstrual cycle
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to analyse condtion of asrigdara & treat by ayurveda principles |
fifth day of menstrual cycle for two consecutive menstrual cycles
Observational
Followup fifth day of third Menstrual 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/06/2023 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Asrigdara is a common menstrual disorder affecting women. It is characterized by excessive prolonged menstrual or intermenstrual bleeding which interferes with women’s physical, emotional and social quality of life. In modern science it can be correlated with Abnormal Uterine Bleeding. Dysfunctional uterine bleeding is one among Abnormal uterine bleeding without any clinically detectable Organic Cause. The Rate of prevalence of AUB in India is around 17.9%. In contemporary science management protocol includes interventions like Hormonal therapy, Anti prostaglandins and antifibrinolytic agents and further advices to surgical interventions like uterine curettage, endometrial ablation and Hysterectomy, which has their own limitations, high costs with associated side effects. Ayurvedic classics have described varieties of treatment options in the management of Asrigdara, which are non-hormonal, non-surgical, effective drugs without any adverse effects. Among them Laksha choorna and Pushyanuga choorna are shamana aushadhi’s having properties like kashaya rasa pradhana, pitta shamaka and rakta stambaka in action found to be effective in Asrigdara. Laksha choorna which is a cost effective, commonly available drug and can be prepared easily. Hence the study has been taken as “A Randomized controlled clinical study to evaluate the effect of Laksha choorna in Asrigdara (dysfunctional uterine bleeding)’’. |