| CTRI Number |
CTRI/2026/02/103430 [Registered on: 09/02/2026] Trial Registered Prospectively |
| Last Modified On: |
07/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to see how Ayurvedic Medicine and Enema therapy combinely helps in low Menstrual Bleeding. |
|
Scientific Title of Study
|
A Single Arm Clinical Trial on the Combined Clinical Efficacy Of Krishna Tila Kashaya with Sahacharadi Taila Matrabasti in the Management of Artavakshaya (Hypomennorhhea) |
| 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 Rachna Mishra |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Stri Roga Evam Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India
Hassan
KARNATAKA
573201
India |
| Phone |
7218260391 |
| Fax |
|
| Email |
rachnamishra750@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathima |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Stree Roga Evam Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India
Hassan
KARNATAKA
573201
India |
| Phone |
9611990497 |
| Fax |
|
| Email |
drprathima.jain@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rachna Mishra |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital |
| Address |
Department of Stri Roga Evam Prasuti Tantra Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla Hassan Karnataka India
Hassan
KARNATAKA
573201
India
Hassan
KARNATAKA
573201
India |
| Phone |
7218260391 |
| Fax |
|
| Email |
rachnamishra750@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College of Ayurveda and Hospital,
Thanniruhalla, Hassan, Karnataka 573201 |
|
|
Primary Sponsor
|
| Name |
SDM College of Ayurveda and Hospital |
| Address |
Thanniruhalla, Hassan 573201 |
| Type of Sponsor |
Private medical college |
|
|
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 Rachna Mishra |
SRI DHARAMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL |
OPD AND IPD UNDER ALL DEPARTMENTS OF SRI DHARAMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL,THANNIRUHALLA ,HASSAN 573201 HASSAN KARNATAKA HASSAN
Hassan
KARNATAKA |
07218260391
rachnamishra750@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITION OF ETHICS COMMITEE SRI DHARAMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N91||Absent, scanty and rare menstruation. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krishna Tila Kashaya, Reference: Yogaratnakara – Yonivyapad Chikitsa , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 20 Days, anupAna/sahapAna: Yes(details: Guda), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sahacharadi Taila, Reference: Bhaishajya Ratnavali – Vatavyadhi Chikitsa and Ashtanga Hridaya Vat Vyadhi Chikitsa adhyaya., Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1 Diagnosed with Artavakshaya which is scanty menstruation duration less than 3 days and associated
symptoms like yoni vedana
2 Diagnosed with Hypomenorrhea based on clinical criteria which is menstrual flow less than or equal to 2 days
blood loss less than 30 mL as per PBAC scoring
3 Willing to participate and ready to sign written bilingual informed consent form |
|
| ExclusionCriteria |
| Details |
1 Known cases of Endometriosis, Fibroids, or Congenital Uterine Anomalies
2 Diagnosed with systemic disorders like Diabetes Mellitus, Thyroid Dysfunction
3 Using hormonal contraceptives/ IUD/undergoing IVF/assisted reproductive therapy
4 Lactating women
5 Diagnosed case of severe anaemia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in the duration and quantity of menstrual bleeding
as assessed by PBAC (Pictorial Blood Loss Assessment Chart)
score.
|
60days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Reduction in associated symptoms such as Yoni Vedana
(pain/discomfort).
2 Improvement in subjective parameters like flow pattern and cycle
regularity.
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
01/03/2026 |
| 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="2"
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
|
This study is designed as a single arm, open label clinical trial to evaluate the combined clinical efficacy of Krishna Tila Kashaya administered orally and Sahacharadi Taila Matra Basti given rectally in the management of Artavakshaya or hypomenorrhea in women of reproductive age. Artavakshaya is described in Ayurveda as scanty, delayed and short duration menstruation due to vitiation of Vata and Kapha doshas, leading to impairment of Rasa and Rakta dhatu. In modern medicine, hypomenorrhea is associated with hormonal imbalance, thin endometrium and conditions such as PCOS. Conventional treatments mainly provide symptomatic relief and may have side effects, which creates a need for safer and more holistic treatment options. The selected Ayurvedic formulations are traditionally indicated for improving menstrual flow, pacifying vitiated Vata, clearing channels and nourishing reproductive tissues.
The study includes women aged 18 to 35 years diagnosed with hypomenorrhea and assesses changes in menstrual regularity, duration, quantity of bleeding and associated pain using subjective parameters and PBAC scoring as an objective measure. Krishna Tila Kashaya is expected to act as an artavajanana and agnideepana drug, while Sahacharadi Taila Matra Basti is intended to correct Apana Vata dysfunction, improve circulation in the pelvic region and support tissue nourishment. Through this integrated intervention, the study aims to generate clinical evidence for an effective, safe and cost effective Ayurvedic management protocol for hypomenorrhea, with potential long term benefits for menstrual health and overall reproductive well being. |