| CTRI Number |
CTRI/2026/02/104483 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| 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
|
A Study on Herbal Treatment for Excessive Menstrual Bleeding |
|
Scientific Title of Study
|
A Randomized Controlled Clinical study to evaluate the efficacy of Raktapittahara Kashaya and Musali Khadiradi Kashaya in the management of Asrigdara with special reference to Dysfunctional Uterine Bleeding (DUB) |
| 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 Gauri Dethe |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College & Hospital Koppal Karnataka |
| Address |
OPD No 17 Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka
Koppal
KARNATAKA
583231
India |
| Phone |
8379058574 |
| Fax |
|
| Email |
gauridethe2596@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreeja V |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College & Hospital Koppal Karnataka |
| Address |
OPD No 17 Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka
Koppal
KARNATAKA
583231
India |
| Phone |
8971432678 |
| Fax |
|
| Email |
dr.sreejarun@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreeja V |
| Designation |
HOD AND PROFESSOR |
| Affiliation |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College & Hospital Koppal Karnataka |
| Address |
OPD No 17 Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka
KARNATAKA
583231
India |
| Phone |
8971432678 |
| Fax |
|
| Email |
dr.sreejarun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Gauri Dethe |
| Address |
OPD No 17 Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka |
| 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 Gauri Dethe |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College & Hospital Koppal Karnataka |
Prasruti Tantra And Stree roga OPD No 17 Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College Koppal Karnataka
Koppal
KARNATAKA |
8379058574
gauridethe2596@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: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: Musalikhadiradi Kashaya , Reference: Sahastrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Nil | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Raktapittahara Kashaya , Reference: Sahastrayogam, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu/Sharakara), Additional Information: -NIL |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Patients fulfilling the diagnostic criteria
Patients with age group of 18-40 years of either married and unmarried women will be included
Patients with Heamoglobin more than 8gm/dl |
|
| ExclusionCriteria |
| Details |
Pelvic Inflammatory Disease, Benign and Malignant growth in the uterus
Patients with IUCD and patients taking OCP
Patients with systemic and endocrine disorders interfering with the present study including HTN, DM, Thyroid Dysfunction, PCOS.
Patient with bleeding disorder or Coagulopathy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.reduction in menstrual bleeding
2.normalisation duration of menstruation and intervals between the menstrual cycles
3. |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Symptomatic relief
2.Improvment in quality of life |
120 Days |
|
|
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 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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
|
Menstruation is the visible manifestation of cyclic physiological uterine bleeding due to shedding of the endometrium following invisible interplay of hormones mainly through hypothalamic-pituitary ovarian axis1. Normal flow of menstrual blood represents a women’s reproductive health and wellbeing. In Ayurveda Artava is considered as a Updhatu of Rasa Dhatu and Rakta Dhatu.Asrigdara is a disease manifesting as excessive bleeding per vaginum. The majority of the Lakshanas of Asrigdara are due to aggravated Vayu, withholding the Rakta & Pitta vitiated due to Nidana Sevana (Ahara, Vihara & Manosambandhi Nidana), increases its amount, then reaching Rajovaha siras and carrying it to Garbhashaya leading to Atipravrutti of Asruk. Vitiation of Tridosha leads to Agnimandyata which leads to Vikrit Ahara Rasa Nirmana and Rasagni Vaishamya & due to this Vikrit Rasa Dhatu Nirmana takes place. Artava being Upadhatu of Rasa is also vitiated and because of this vikrit artava pramana vriddhi occur which affect the Garbhashayagata Sira which leads to Apana Vayu Dushti and Atyadhik and Chirakala Artavastrava (Asrigdara).Asrigdara is one of the Vikara of Raktavaha Srotas5, symptom of Pitta Avruta Apana Vayu6, Yoni Vyapat Upadrava and Artava Ativruddhi Lakshana7. It is the disorder leading to complications like Pandu, Bhrama, Murcha, Tama, Daha, Vataja roga, Trishna.This condition can be corelated to Dysfunctional uterine bleeding in the contemporary sciences. The condition is characterized by excessive or prolonged blood loss during menstruation with or without bleeding in intermenstrual period9, which is defined as a state of abnormal bleeding without any clinically detectable organic pelvic pathology. Conventional western medicine offers the use of COCs, Progestins, Androgens & agonist of Gonadotropin- releasing Hormone (GnRH), NSAIDs12. Side effects of COCs include increased risk of venous and arterial Thromboembolism (DVT, MI, stroke), mild increase in blood pressure, and possible increases breast and cervical cancer risk.The treatment principles of Raktayoni are adopted in Asrigdara, the haemostatic drugs should be used in the management of Asrigdara.14 Keeping this in mind Raktapittahara Kashaya15 is selected for the study in comparision with Musali Khadiradi Kashaya. Raktapittahara Kashaya is having Pittavatahara karma and acts as Deepaka pachak, Rakta Stambhaka, Grahi, Rasayan and Brimhana. |