| CTRI Number |
CTRI/2025/03/082965 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| 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 |
|
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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: 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: - |
|
|
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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.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
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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)= "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)
|
07/04/2025 |
| 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="4"
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
|
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Brief Summary
|
Acharya Sushruta, an ancient Indian physician, described the features of Artava Kshaya as delayed and scanty menstruation associated with pelvic pain. This is similar to the modern medical conditions of oligomenorrhea and hypomenorrhea. The modern scientific treatment for oligomenorrhea and hypomenorrhea is hormonal therapy, such as oral contraceptive pills. However, hormonal therapy is a temporary solution with many adverse effects, such as obesity, amenorrhea, endometrial cancer, and liver disease. Ayurvedic medicine offers a non-hormonal approach to the treatment of oligomenorrhea and hypomenorrhea. Ayurvedic herb such as Krishna Tila have been shown to be effective in increasing menstrual flow and regulating the menstrual cycle. A safe and effective Ayurvedic non-hormonal drug formulation for the treatment of oligomenorrhea and hypomenorrhea.in present study Ajamodadi Churna has been choosen because Acharaya Sushruta said to use Agneya Dravya used in treatment of Artava Kshaya AIM Conceptual Study of Artava Updhatu w.s.r. to Artavam Shonitam Tvaagneyam with its Applied Aspect in Artava Kshaya. OBJECTIVES· To study concept of Artava Updhatu · To study the detail etiopathogenesis of the Artava Kshaya. · To Review of Ayurvedic and modern literatures on Artava Kshaya. · To evaluate the clinical efficacy of the two selected formulations in Artava Kshaya. HYPOTHESIS NULL HYPOTHESIS (H0) Ajamodadi Churna orally is not effective in Artava Kshaya in comparison to Krishna Tila Kwatha.
ALTERNATIVE HYPOTHESIS (H1) Ajamodadi Churna orally is more effective in Artava Kshaya in comparison to Krishna Tila Kwatha.
ALTERNATIVE HYPOTHESIS (H2) Ajamodadi Churna orally is equal effective in Artava Kshaya in comparison to Krishna Tila Kwatha.
ALTERNATIVE HYPOTHESIS (H3) Ajamodadi Churna orally is less effective in Artava Kshaya in comparison to Krishna Tila Kwatha.
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