| CTRI Number |
CTRI/2026/02/103678 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| 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
|
Clinical study to evaluate the Effect of Sheetakalyanak Ghrita in Artavakashya |
|
Scientific Title of Study
|
Randomised Controlled Clinical Study To Evaluate The Efficacy Of Sheetakalyanak Ghrita in the Management of Artavaksahya (Oligo-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 Rathod Devalrani Bhausaheb |
| Designation |
PG Scholar |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE 1ST FLOOR DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE
SIDDHANT NAGAR TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9309153163 |
| Fax |
|
| Email |
devalranirathod@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukanya Patil |
| Designation |
Professor |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE 1ST FLOOR DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE
SIDDHANT NAGAR TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9113611554 |
| Fax |
|
| Email |
drsukanyapatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rathod Devalrani Bhausaheb |
| Designation |
PG Scholar |
| Affiliation |
SDMTs AMC Post Graduation Centre Terdal |
| Address |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE 1ST FLOOR DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE
SIDDHANT NAGAR TERDAL
Bagalkot
KARNATAKA
587315
India |
| Phone |
9309153163 |
| Fax |
|
| Email |
devalranirathod@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Terdal Bagalkot 587315 |
|
|
Primary Sponsor
|
| Name |
Dr Rathod Devalrani Bhausaheb |
| Address |
SDM Trusts Ayurvedic Medical College 1st Floor Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Terdal 587315 |
| 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 Rathod Devalrani Bhausaheb |
Padma Ayurvedic Hospital And Research Centre |
SDM TRUSTS AYURVEDIC MEDICAL COLLEGE DANIGOND POST GRADUATE CENTRE AND PADMA AYURVEDIC HOSPITAL AND RESEARCH CENTRE
SIDDHANT NAGAR TERDAL
Bagalkot
KARNATAKA |
9309153163
devalranirathod@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMTs Ayurvedic Medical College And Padma Ayurvedic Hospital INSTITUTIONAL ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brhat Shatavari Ghrita , Reference: Charak Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Sukoshna jala), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sheetkalyanaka Ghrita, Reference: Yogaratnakara, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Sukoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Menses at an interval longer than 35 days.
2.Subjects aged from 15–35 years.
3.Bleeding less than 2 days.
4.Both married and unmarried.
5.Subject willing for consent. |
|
| ExclusionCriteria |
| Details |
1.Lactating women.
2.Woman on OCPs and IUCD.
3.Hb% less than 7 gm.
4.Known case of Pelvic Pathology or Malignancy.
5.Known case of PCOS Condition |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Trial Drug on Improvement in the symptoms of Artavakshaya(Oligo-hypomenorrhoea) |
Every 5th day of Menstrual cycle for 3 consecutive cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of trial drug and Adverse Drug Reaction Aggravation of Symptoms of Artavakshaya |
Every 5th day of Menstrual cycle for 3 consecutive cycles |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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="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 a vital physiological function reflecting a woman’s reproductive health. Normally, the menstrual cycle occurs every 21–35 days with bleeding lasting 4–5 days. Due to modern lifestyle changes, many women suffer from menstrual disorders such as AUB, DUB, PCOD, infertility, and especially oligomenorrhea and hypomenorrhea. In Ayurveda, menstruation is referred to as Artava, and its disorders are described under conditions like Artavakshaya. This condition correlates with oligomenorrhea and hypomenorrhea in modern medicine. Contemporary treatment mainly relies on hormonal therapy, which is costly and associated with long-term side effects. According to Ayurveda, Artavakshaya is caused by Vata-Kapha imbalance leading to obstruction in the flow of Artava. Hence, there is a need for a safe, cost-effective and non-hormonal treatment. This study aims to evaluate the effectiveness of Sheetakalyanka Ghrita (trial drug) compared with Brihat Shatavari Ghrita (control drug) in the management of Artavakshaya (Oligo-hypomenorrhoea ) Hence, an attempt is made to validate the role of Sheetakalyanka Ghrita in the management of Artavakshaya (Oligo-hypomenorrhoea ) |