| CTRI Number |
CTRI/2025/07/090132 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Ayurvedic Remidies for Light Menstrual Flow (Hypomenorrhea) Artavakshaya |
|
Scientific Title of Study
|
A Comaparative Clinical Study To Evaluate The Efficacy of Tilashelukarvi Kwatha &Venuparvadi Kwatha in the Management of Artava Kshaya with special reference to Hypomenorrhea |
| 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 Preeti |
| Designation |
PG scholar Prasuti Tantra&Stree Roga |
| Affiliation |
Rajarajeshwari Ayurvedic Medical College and Hospital PG Center Humnabad Karnataka |
| Address |
Department Of PG Studies in Prasuti Tantra&Stree Roga Rajarajeshwari Ayurvedic Medical College Hospital &PG Center Humnabad,Dist Bidar
Bidar
KARNATAKA
585330
India |
| Phone |
9611632600 |
| Fax |
|
| Email |
preetikurne@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Sudhakar |
| Designation |
Professor&Hod |
| Affiliation |
Rajarajeshwari Ayurvedic Medical College and Hospital PG Center Humnabad Karnataka |
| Address |
Department Of PG Studies in Prasuti Tantra&Stree Roga Rajarajeshwari Ayurvedic Medical College Hospital &PG Center Humnabad,Dist Bidar
Bidar
KARNATAKA
585330
India |
| Phone |
9866691084 |
| Fax |
|
| Email |
dr.nsr65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Sudhakar |
| Designation |
Professor&Hod |
| Affiliation |
Rajarajeshwari Ayurvedic Medical College and Hospital PG Center Humnabad Karnataka |
| Address |
Department Of PG Studies in Prasuti Tantra&Stree Roga Rajarajeshwari Ayurvedic Medical College Hospital &PG Center Humnabad,Dist Bidar
Bidar
KARNATAKA
585330
India |
| Phone |
9866691084 |
| Fax |
|
| Email |
dr.nsr65@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeshwari Ayurvedic Medical College Hospital & Research PG Center Humnabad 585330,Bidr dist India |
|
|
Primary Sponsor
|
| Name |
Rajarajeshwari Ayurvedic Medical College Hospital & Research PG Center Humnabad |
| Address |
Rajarajeshwari Ayurvedic Medical College Hospital & Research PG Center Humnabad,Dist Bidar Karnataka-585330 |
| 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 Preeti |
Rajarajeshwari Ayurvedic Medical College &Hospital |
Department Of PG Studies in Prasuti Tantra&Stree Roga Rajarajeshwari Ayurvedic Medical College Hospital &PG Center Humnabad,Dist Bidar
Bidar
KARNATAKA |
9611632600
preetikurne@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Rajarajeshwari Ayurvedic Medical College &Hospital Humnabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Venuparvadi Kwatha, Reference: Siddha Bhaishajya Manimala Stree Roga Chikitsaadya shloka no 7, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Guda), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Tilashelukarvi Kwatha, Reference: Yogaratnakara Yonivyapada Chikitsaadya sholka no 25, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Guda), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Age between 16-40 years.
2. Duration of flow less than 2 days.
3. Reduced in quantity.
4. Pain during menses.
5. Patients suffering from 2 consecutive cycle with Hypomenorrhoea |
|
| ExclusionCriteria |
| Details |
1. Pregnant women & Lactating mother.
2. Patients with polymenorrhoea.
3. Patients suffering from any systemic diseases as D.M., T.B, Hypertension.
4. Woman taking OCPs.
5. Hb level less than 7gm%.
6. Congenital anomalies of reproductive organs &Sexually transmitted diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To know the efficacy of Tilashelukarvi Kwatha and Venuparvadi Kwatha in the management of Artavakshaya with special reference to hypomenorrhea. |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
OBJECTIVES :-.
1. To Evaluate the Efficacy of Tilashelukarvikwatha in the management of Artavakshaya w.s.r to hypomenorrhea.
2. To Evaluate the Efficacy of Venuparvadikwatha in the management of Artavakshaya w.s.r to hypomenorrhea.
3. To compare the efficacy of Tilashelukarvikwatha & Venuparvadikwath in the management of Artavakshaya w.s.r to hypomenorrhea |
21 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)
|
14/07/2025 |
| 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 Yet Recruiting |
| 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
|
Artavakshaya is one of the most common gynaecological problem.Artavakshaya is characterised by yathochit kala adarsham (Not seen at proper time),alpaartava(Scanty menses) And yonivedana (pain in vagina).In this modern era ,the sedentary life, food habits, stress, strain, lack of physical exercise, restlessness etc. Affect the health of a woman and ultimately it leads to menstrual abnormalities.
Management of Hypomenorrhea in modern science includes hormonal therapy and other drugs which have serious side effects like breast Tenderness,Diarrhoea,Vaginal bleeding,Unusal hair growth etc. Hence there is a need for Ayurvedic management.
In Ayurveda management according to Acharya Sushrutha the Artavakshaya should be treated by the use of purifying measures and Agneya dravays
Tilashelukarvikwatha mentioned in Yogaratnakara Yonivyapada Chikitsa and Venuparvadikwatha mentioned in Siddha BhaishajyaManimala Streeroga Chikitsaadhya have been selected in Artavakshaya. Hence Tilashelukarvikwatha having ingredients Tila,Shelu and Karvi and Venuparvadikwatha having ingredients Venu and Shatapushpa. Both are having Artavapravartaka properties like Ushna virya,Katu rasa,Tikshnaguna.
Hence present study will be aimed to evalute and compare the effect of Tilashelukarvi kwatha and venuparvadi kwatha in Artavakshaya with special reference to Olgohypomenorrhea |
|