| CTRI Number |
CTRI/2025/07/091134 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| 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
|
Efficacy of Jyotishmatyadi Churna will be check in Scanty menses |
|
Scientific Title of Study
|
Randomized controlled clinical study to evaluate the efficacy of Jyotishmatyadi Churna in the management of Artava Kshaya |
| 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 Shital Santosh Pariskar |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 Aurangabad MAHARASHTRA 431011 India |
| Phone |
7743969727 |
| Fax |
|
| Email |
shitalpariskar5005@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amol Anandrao Havale |
| Designation |
Associate Professor |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
| Address |
OPD No 19 Streerog and Prasuti Tantra Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India OPD No 19 Streerog and Prasuti Tantra Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra Aurangabad MAHARASHTRA 431011 India |
| Phone |
9822538957 |
| Fax |
|
| Email |
amolhavale@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shital Santosh Pariskar |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 |
| Address |
OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad
Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad
Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India Aurangabad MAHARASHTRA 431011 India |
| Phone |
7743969727 |
| Fax |
|
| Email |
shitalpariskar5005@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431001 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad India 431011 |
| Address |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| 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 Shital Santosh Pariskar |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra |
OPD No 19 Prasuti Tantra and Streeroga Department C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad
Maharashtra India 431011
Aurangabad
MAHARASHTRA
Aurangabad MAHARASHTRA |
07743969727
shitalpariskar5005@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N915||Oligomenorrhea, unspecified. Ayurveda Condition: ARTAVAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jyotishmatyadi Churna, Reference: Bhaishajyaratnavali ( Yonivyapad Rogadhikar 67/29 ), Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: - Godudha), Additional Information: - Duration of treatment -3 days
Follow up - 2 | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shatpushpa Churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: - Ghrut), Additional Information: -Duration of Treatment - 2 months daily
Follow up - 2 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Married and Unmarried woman.
2.Bleeding , Spotting less than 2 days.
3.Infrequent Menses at interval longer than 35 days.
4.Patients presenting with Pratyatma lakshana of Artava Kshaya i.e.
a. Athochitakala Adarshanam
b. Alpartavam
c. Yonivedana |
|
| ExclusionCriteria |
| Details |
1.Patients with Systemic Disorders like DM, HTN, HIV, Congenital Anomalies of Female Genital Tract.
2.Patients with Malnutrition, Severe Anaemia i.e. Hb below 7gm percent.
3.Pregnant and Lactating Women.
4.Women taking OC Pills.
5.Patients age below 18 yrs and above 45 yrs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of Jyotishmatyadi Churna in the management of Artava Kshaya. |
Baseline- 30th, 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study Artava Kshaya according to Ayurveda.
2. To study Oligomenorrhoea and Hypomenorrhoea according to Modern.
3. To compare the effect of Jyotishmatyadi Churna and Shatpushpa
Churna in the management of Artava Kshaya. |
Baseline- 30th, 60th day |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/08/2025 |
| 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
|
As per Ayurveda woman is the origin of human life. As we all know Women are the base of family & Nation. So it is very important to provide better health & take care of important facilities to them about disease condition and their management. Various cyclic physiological processes taking place in our body for Maintainance of health. If there is any alteration, it will give rise to Pathological Conditions. Among all pathologies, the most common is Menstrual Irregularities in Gynaecological problems. They are in the form of Oligomenorrhoea and Hypomenorrhoea which shows the similarities with Artava kshaya. Features are delayed and scanty menstruation i.e. Yathochitkal adarshanam ,Alpata, Yonivedana. As Reproductive health of Woman is determined by Menstrual Cycle, it has been mandatory to have regular Menstrual cycle monthly. Due to Sedentary Lifestyle, these complaints of irregular Menses & Scanty menses is increased in its prevalence rate. As increasing the prevalence, it requires more attention & counselling with appropriate treatment. Many Previous researches having Basti as a treatment or Other oral drugs given for more duration. So there is need to achieve result in short time duration by medication. In Bhaishajya Ratnavali, Jyotishmatyadi dravyas indicated as Artava pravartan which indudes Jyotishmati , Sarjikshar, Vacha & Vijaysar. All these drugs are Ushna Virya and Aagneya gun pradhan. Study will be conducted on 100 diagnosed patients of Artava Kshaya. Written consent will be taken. Initial assessment will be done. Patient treated with interventional group Jyotishmatyadi Churna and control group Shatapushpa Churna.Patients will be assessed at follow ups. Observation and Results will be noted and Statistical Analysis, Discussion and Conclusion will be drawn. |