| CTRI Number |
CTRI/2025/03/082965 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Balance Your Menstrual Cycle with Ayurvedic Remedies for oligomenorrhea and hypomenorrhea |
|
Scientific Title of Study
|
Conceptual Study of Artava Updhatu with Special Refferance to Artavam Shonitam Tvaagneyam with its Applied Aspect in 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 Avani B Gagiya |
| Designation |
MD Scholar |
| Affiliation |
Government Ayurveda College Junagadh, |
| Address |
Dept. of Ayurveda Samhita Evam Siddhant, Government Ayurveda College Junagadh, Gujarat
Junagadh
Gujarat
362001
India
Junagadh
GUJARAT
362001
India |
| Phone |
7203860980 |
| Fax |
|
| Email |
avniahir063@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shivdayal Sharma |
| Designation |
Professor Department of Ayurveda Samhita Evam Siddhant, |
| Affiliation |
Government Ayurveda College Junagadh, |
| Address |
Dept. of Ayurveda Samhita Evam Siddhant, Government Ayurveda College Junagadh, Gujarat
Junagadh
GUJARAT
362001
India |
| Phone |
9016830341 |
| Fax |
|
| Email |
ayursdsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Shivdayal Sharma |
| Designation |
Professor Department of Ayurveda Samhita Evam Siddhant, |
| Affiliation |
Government Ayurveda College Junagadh, |
| Address |
Dept. of Ayurveda Samhita Evam Siddhant, Government Ayurveda College Junagadh, Gujarat
Junagadh
GUJARAT
362001
India |
| Phone |
9016830341 |
| Fax |
|
| Email |
ayursdsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| As I am student of government institute, Raw drug will be supplied by one of the two government pharmacies of Gujarat i.e Gvernment Ayurveda Pharmacy Rajpipala - 393145 or Government Ayurved Pharmacy Vadodara 390019 state: Gujarat, Country: india |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda College Junagadh, Gujrat |
| Address |
Pancheshwar road,
Junagadh-362001
Gujarat
362001
India |
| Type of Sponsor |
Government 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 Avani B Gagiya |
Department of Ayurved Samhita Evam Siddhant Government Ayurveda Hospital Junagadh |
Pancheshwar road, Junagadh-362001 Junagadh
GUJARAT
Junagadh
GUJARAT |
07203860980
avniahir063@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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: Ajamodadi churna, Reference: Sharangadhar Samhita Madhyam khand Chapter 6, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: guda), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Krishna Tila Kwatha, Reference: Yoga ratanakar Yoni vyapad chikitsa chapter 5, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 2 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 irrespective of marital status
2)Symptoms of Artava Kshaya: Yathochitakala Adarshan-Menstruation at the interval of more than 35 days, Alpata-Scanty menstruation, Yonivedana -pain in pelvic region.
3)Menses For 2 days or less with 1 or 2 pad /day or spotting menses
|
|
| ExclusionCriteria |
| Details |
1)Age of patients less than 16 years and more than 40 years.
2)Patients on Oral contraceptive pills.
3)Peri Menopause & Post Menopause women.
4)Patients with Intra uterine device.
5)Patients with known case of diabetes mellitus, severe anemia, uncontrolled hypertension, Tuberculosis, Asthma, Chronic Psychosomatic Disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration, amount, regularity of menses |
After each menstrual cycle for 3 consecutive cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration, amount, Pain, regularity of menses |
On 3 consecutive cycle |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| Date of Study Completion (India) |
16/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Both treatments produced improvement in
the clinical features of Artava Kshaya. However, the available complete
records showed a greater descriptive reduction in Group B than
Group A.
The reduction in aggregate symptom
score was approximately 72.09% with Krishan
Tila Kwatha and 84.86% with Ajamodadi Churna. |