| CTRI Number |
CTRI/2025/05/087715 [Registered on: 27/05/2025] Trial Registered Prospectively |
| Last Modified On: |
13/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of Shatavari Guda and Kushmandaka Rasayana in the management of Heavy Menstrual Bleeding |
|
Scientific Title of Study
|
AN OPEN LABEL RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF SHATAVARI GUDA AND KUSHMANDAKA RASAYANA IN HEAVY MENSTRUAL BLEEDING |
| 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 Raut Deepali Lahu |
| Designation |
Pg Scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital mysuru |
| Address |
OPD No.9, Department of Prasuti Tantra evam Stree Roga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028
OPD No.9, Department of Prasuti Tantra evam Stree Roga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028
Mysore
KARNATAKA
570028
India |
| Phone |
7387015487 |
| Fax |
|
| Email |
deepaliraut1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tejaswini K R |
| Designation |
Associate Professor |
| Affiliation |
JSS Ayurveda Medical College And Hospital mysuru |
| Address |
OPD No.9, Department of Prasuti Tantra evam Stree Roga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028
OPD No.9, Department of Prasuti Tantra evam Stree Roga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028
Mysore
KARNATAKA
570028
India |
| Phone |
8762409110 |
| Fax |
|
| Email |
tejteju9@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raut Deepali Lahu |
| Designation |
Pg Scholar |
| Affiliation |
JSS Ayurveda Medical College And Hospital mysuru |
| Address |
OPD No.9, Department of Prasuti Tantra evam Stree Roga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028
OPD No.9, Department of Prasuti Tantra evam Stree Roga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028
Mysore
KARNATAKA
570028
India |
| Phone |
7387015487 |
| Fax |
|
| Email |
deepaliraut1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Raut Deepali Lahu |
| Address |
OPD No.9, Department of Prasuti Tantra evam Stree Roga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India 570028 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL |
JSS AYURVEDA MEDICAL COLLEGE AND HOSPITAL LALITHADRIPURA ROAD MYSURU KARNATAKA 570028 ALANAHALLI MYSURU |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Raut Deepali Lahu |
JSS Ayurveda Hospital |
OPD No.9, Department of Prasuti Tantra evam Stree Roga, JSS Ayurveda Medical College and Hospital Lalithadripura Road Mysuru Karnataka India
570028
Mysore
KARNATAKA |
7387015487
deepaliraut1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee JSS Ayurveda Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular 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: Shatavari guda, Reference: Dr. K. Nishteswar and Dr. R. Vidyanath,Sahasrayogam,Edition 4,Varanasi,Chowkhamba Sanskrit Series Office,Chap.7,P.258,259., Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushmandaka rasayana, Reference: Dr. K. Nishteswar and Dr. R. Vidyanath ,Sahasrayogam,Edition 4,Varanasi, Chowkhamba Sanskrit Series Office,Chap.7,P.254,255., Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) SUBJECTS FULFILLING THE DIAGNOSTIC CRITERIA
2) SUBJECTS WITH AGE GROUP 15 TO 45 YEARS
3) SUBJECTS WITH HEMOGLOBIN MORE THAN EQUAL TO 10
GRAMS |
|
| ExclusionCriteria |
| Details |
1) Subjects with IUCD.
2) Subjects on oral Contraceptive pills.
3) Benign and malignant growth in reproductive
organs.
4) Subjects with K/C/O metabolic and systemic
disorders like Diabetes mellitus, Thyroid
disorder, Hypertension.
5) Subjects with miscarriage/active bleeding
followed by abortion.
6) K/C/O Coagulation Disorder, H/O previous
thrombosis.
7) Lactating women.
|
|
|
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 |
| bleeding will be controlled |
3 months of continuous use will help in controlling heavy menstrual bleeding |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| loss of blood due to heavy cycles leads to anemia, which can be prevented |
3 months regular use |
|
|
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)
|
30/05/2025 |
| 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
|
Women’s health is point of concern for herself, family and society because any physical or mental variations can disturb her normal menstrual cycle. Regular menstruation is a result of coordinated HPO Axis. The duration of menstrual cycle is usually 28 to 30 days. The duration of bleeding is about five days and estimated blood loss is 20 to 80 ml.[1] In present days, due to changing lifestyle with food habits, incidence of excessive and irregular menstrual bleeding is increasing day by day because of which women need to take off from the work. Heavy menstrual bleeding affect not just physical but also social, emotional and psychological well being & quality of life. Heavy menstrual bleeding is the medical term for menstruation with abnormally heavy or prolonged bleeding. International Federation of Gynaecology and Obstetrics (FIGO) Menstrual Disorders Working Group has proposed abandoning the use of one common term, dysfunctional uterine bleeding (DUB), while continuing to use the terms abnormal uterine bleeding (AUB) and heavy menstrual bleeding (HMB). It affects 30% of women during their reproductive years.[2] Prevalence of Menorrhagia in India is 17%.[3] The diseases Asrigdara explained in Ayurveda may be correlated with condition of heavy menstrual bleeding. According to Acharya Sushruta, excessive and prolonged bleeding during menstruation or even in intermenstrual period, different from the features of normal menstrual blood is called Asrigdara [5] . Asrigdara or abnormal uterine bleeding is regular or irregular with alteration in amount or duration of menstrual blood loss, commonly implies to excessive irregular menstrual bleeding or essential menorrhagia. Various conditions which resemble Menorrhagia are termed as follows in Ayurveda Texts- Raktapradar/Asrigdara Raktayoni Yonivyapad Lohitkshara Yonivyapad,etc.
Various treatment modalities like hormonal therapy antiprostaglandins and antifibrinolytic agents are available in modern medicine. Many side effects have been observed, because of these medications,including hormonal imbalance.There is always a need for safe and alternative treatment. Keeping this in mind, It was decided to select a herbal medicine for the management of Heavy Menstrual Bleeding. As per Ayurvedic references SHATAVARI GUDA and KUSHMANDAKA RASAYANA is considered as most useful remedy for Menstrual disorders. The present study focused on the effect of SHATAVARI GUDA and KUSHMANDAKA RASAYANA on Heavy Menstrual Bleeding.
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