| CTRI Number |
CTRI/2025/09/094513 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study compares Jyotishmatyadi churna and shatapushpa churna for artava kshaya (Scanty periods) in women using a randomised trial to assess their effectiveness through oral intake. |
|
Scientific Title of Study
|
Randomised Controlled Study of Jyotishmatyadi Churna in The
Management of Artava Kshaya with Special Reference to Oligomenorrhea. |
| 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 Pooja Suradkar |
| Designation |
M.S.Prasuti tantra evum streeroga |
| Affiliation |
L.K.R.Ayurvedic Mahavidyalay PG Training and Research center , Gadhinglaj. |
| Address |
L.K.R.Ayurvedic Mahavidyalay, Prasutitantra and streeroga department,OPD NO -05, P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502 L.K.R.Ayurvedic Mahavidyalay,Prasutitantra and streeroga department , OPD NO -05,P-2,M.I.D.C.area Gadhinglaj,Dist.Kolhapur Pincode - 416502 Kolhapur MAHARASHTRA 416502 India |
| Phone |
7887766856 |
| Fax |
|
| Email |
dhanraj8067@rediffmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Suhas Thorat |
| Designation |
M.S.Prasuti tantra evum streeroga |
| Affiliation |
L.K.R.Ayurvedic Mahavidyalay PG Training and Research center , Gadhinglaj. |
| Address |
L.K.R.Ayurvedic Mahavidyalay,Prasutitantra and streeroga department , OPD NO -05,P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502 L.K.R.Ayurvedic Mahavidyalay,Prasutitantra and streeroga department,OPD NO -05,P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502 Kolhapur MAHARASHTRA 416502 India |
| Phone |
9850366952 |
| Fax |
|
| Email |
drsuhasthorat26@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suhas Thorat |
| Designation |
M.S.Prasuti tantra evum streeroga |
| Affiliation |
L.K.R.Ayurvedic Mahavidyalay PG Training and Research center , Gadhinglaj. |
| Address |
L.K.R.Ayurvedic Mahavidyalay,Prasutitantra and streeroga department , OPD NO -05,P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502 L.K.R.Ayurvedic Mahavidyalay ,Prasutitantra and streeroga department,OPD NO -05,P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502 Kolhapur MAHARASHTRA 416502 India |
| Phone |
9850366952 |
| Fax |
|
| Email |
drsuhasthorat26@gmail.com |
|
|
Source of Monetary or Material Support
|
| L.K.R.Ayurvedic Mahavidyalay PG Training and Research center , Gadhinglaj,
Prasutitantra and streeroga department , OPD NO -05,
P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502 |
|
|
Primary Sponsor
|
| Name |
Dr. Pooja Suradkar |
| Address |
L.K.R.Ayurvedic Mahavidyalay PG Training and Research center , Gadhinglaj,
Prasutitantra and streeroga department , OPD NO -05,
P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Suhas Thorat |
L.K.R.Ayurvedic Mahavidyalay PG Training and Research center , Gadhinglaj,
Prasutitantra and streeroga department , OPD NO -05,
P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Suhas Thorat |
L.K.R. Ayurvedic Mahavidyalay |
L.K.R.Ayurvedic Mahavidyalay Prasutitantra and streeroga department ,OPD NO -05,P-2,M.I.D.C.area Gadhinglaj Dist. Kolhapur Pincode - 416502
Kolhapur MAHARASHTRA |
9850366952
drsuhasthorat26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Late Kedari Ayurvedic Mahavidyalaya and PG Training and Research Centre Gadhinglaj, Kolhapur. |
Approved |
|
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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: Bhavprakash chikitsa , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -sheet dugdh), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatapushpa Churna, Reference: Kashyapa kalpasthan, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Goghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Married/unmarried patients suffering from any two of the
following cardinal symptoms of Artavakshaya:
a. If the interval between 2 menstrual cycles exceeds more than 35 days.
b. Yoni Vedana - Pain during menstruation in internal genital organs. |
|
| ExclusionCriteria |
| Details |
a.Breastfeeding within the past 3 months.
b.History of intake of oral contraceptive or ovulation inducing agent within the past 3 months.
3.Established endocrine disorders.
4.Interval between 2 consecutive menstrual cycles is more than 6 months.
5.Oligomenorrhea with hypermenorrhoea.
6.Patient suffering from any uterine or pelvic pathology.
7.Patient with any malignancy or anatomical defect.
8.Patient suffering from any severe systemic disorders.
9.Intake of psychoactive drugs or antiepileptic drugs (valproic acid). |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome focuses on the clinical efficacy of Jyotishmatyadi churna vs shatapushpadi churna in managing aartav kshaya. It will be assessed based on sysmtomatic relief (pain)and objective parameters (Artavpraman).Assesments will occur at baseline , during treatment ,post treatment and follow ups.
Study aims to compare the effects of Jyotishmatyadi churna and shatapushpadi churna in managing artav kshaya,focusing on internal applications.
|
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study aims to compare the effects of Jyotishmatyadi churna and shatapushpadi churna in managing artav kshaya,focusing on internal applications.
1. Detailed analysis of guna,karma of Jyotishmatyadi churna and shatapushpadi churna.
2. A comprehensive review of artav kshaya based on ayurvedic samhitas.
3. A detailed study of aartavkshaya from a modern persective.
4. A comparative assessment of the efficacy of both churnas in managing symptoms. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
21/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dhanraj8067@rediffmail.com].
- For how long will this data be available start date provided 01-10-2025 and end date provided 31-05-2026?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Artava Kshaya, described in Ayurveda under Yonivyapad and Artava Vikara, presents as irregular, scanty, or painful menstruation and is correlated with oligomenorrhea and scanty menses in modern science. Conventional allopathic management relies on hormonal therapy with temporary effects and adverse reactions. Ayurveda emphasizes root-cause management using Agneya dravyas that enhance Rasa and Rakta Dhatu, balancing Vata-Pitta. Jyotishmatyadi Churna, with uterine restorative and Artavajanana properties, is selected as a safe, cost-effective, and holistic option for managing Artava Kshaya. |