| CTRI Number |
CTRI/2024/06/069617 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Nasya and Nasya with choorna orally] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study The Effect Of Ayurvedic Formulation In Artavkshaya (Scanty and Delayed Menses) |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Efficacy Of Shatpushpa Taila Nasya And Shatpushpa Taila Nasya Along With Shatpushpa Churna Orally In Artavkshaya W.S.R To Oligomenorrhea And Hypomenorrhea |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saniya Meer |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Room No.309, Department Of Prasuti Tantra Evum Stri Roga, Parul University , Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9773142787 |
| Fax |
|
| Email |
meersaniya9876@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rita Makim |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Room No.309, Department Of Prasuti Tantra evum Stri Roga, Parul University , Limda, Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7990727524 |
| Fax |
|
| Email |
ritamakim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rita Makim |
| Designation |
Professor |
| Affiliation |
Parul Institute Of Ayurveda |
| Address |
Room No.309, Department Of Prasuti Tantra evum Stri Roga, Parul University , Limda, Vadodara
GUJARAT
391760
India |
| Phone |
7990727524 |
| Fax |
|
| Email |
ritamakim@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital ,Parul University, Vadodara |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurveda |
| Address |
Room No 309, department of Prasuti Tantra evum Stri Roga, Parul Institute Of Ayurveda |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Saniya Meer |
Parul Ayurved Hospital |
OPD NO 104, Stri Roga Evum Prasuti Tantra OPD, Parul Ayurved Hospital, Parul University PO Limda, Tal Waghodia, Vadodara
Vadodara
GUJARAT |
9773142787
meersaniya9876@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Parul Institute Of Ayurved, Parul University |
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 | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astanga Hridaya, Procedure details: 2 Drops In Each Nostrils From 7 days Before LMP Till Menses Comes.)
(1) Medicine Name: Shatpushpa Taila, Reference: Kashyap Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Astanga Hridaya, Procedure details: 2 Drops In Each Nostrils From 7 days Before LMP Till Menses Comes.)
(1) Medicine Name: Shatpushpa Taila, Reference: Kashyap Samhita, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 7 Days(2) Medicine Name: Shatpushpa Churna, Reference: Kashyap Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 2 Months |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age Between 15-35 Years Irrespective Of Marital Status
Symptoms of Artavkshay- yathochitkaladarshana(oligomenorrhea),artavalpata(hypomenorrhea), yonivedana (any of two)
Menses for 2 days or less, 1to 2 pad per day or spottimg menses
Menstrual cycle of 28 to 45 cycle
Patient is willing to take part in study and ready to give consent for study.
|
|
| ExclusionCriteria |
| Details |
Peri Menopause and Post Menopause Women
Patients on OCPs
Patients with IUCDs.
Patients with knowing case of Thyroid Dysfunction, DM, uncontrolled HTN, Severe Anemia (8mg/DL) Asthma, Tuberculosis, Congenital Abnormalities of Reproductive System, Chronic Psychosomatic disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
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 |
| changes in Body mass index |
after each menstrual cycle for 3 consecutive cycle |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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
|
Aim : To evaluate the efficacy of shatpushpa taila nasya along with Shatpushpa churna orally in Artavkshaya
Objectives:
To study artavakshaya in detail along with its possible modern correlations
To establish an ayurvedic medication as a remedy for artavakshaya.
To compare the efficacy of shatpushpa taila nasya and shatpushpataila nasya along with shatpushpa choorna in Artavkshay Hypothesis : Null hypothesis (H0) : Shatpushpa taila Nasya along with shatpushpa choorna is not as effective as shatpushpa taila nasya in the management of artakshaya . Alternative Hypothesis- (H1) Shatpushpa taila Nasya along with shatpushpa choorna is as effective as Shatpushpa taila nasya in Artavkshaya . Assesment criteria subjective criteria . a) Duration of Menstrual bleeding:3-5 DAYS (normal duration)-0 ,2 DAYS (moderately short duration)-1 ,1 DAYS (short duration)-2, Spotting (very short duration)-3 b) Interval between two menstrual cycle : 24-34 DAYS -score 0, 35-39 DAYS- score 1 ,40-45 DAYS score-2, ABOVE 45 score- 3 c) Quantity of bleeding or Using number of Pad /Day during Period: >2 Pad/day-0 ,2 Pad/day-1 ,1 Pad/day-2 , Spotting-3 d) Pain during Menstrual bleeding (Pelvic Pain) No pain-0, Mild (Able to do daily activity) -1,Moderate (Daily activities affected, need to take analgesics) -2 ,Severe (Daily activities affected ,pain continuous after taking analgesics) - 3 e) Pattern of Menstrual cycle (Regular/Irregular) Regular cycle-0, Irregular cyclep-1. f) Bleeding /Spotting between periods : Absent- 0, Present-1 g) Consistency of Menstrual bleeding :Thin-0, Mucoid -1, Mucoid with clots -2 ,Clots -3 h) Color of Bleeding/Srava : Shuddha Rakta Srava - 0, Arun,KrishnaSrava (Vatajadushti) or -Neela,PittaSrava (Pittajadushti) or Shukla, PchhilaSrava (Kaphajadushti) - 1 i) Backache No pain - 0 , Mild (Able to do daily activity) - 1 ,Moderate (Daily activities affected, need to take analgesics) -2, Severe (Daily activities affected,pain continuous after taking analgesics) - 3 Objective parameters BMI Underweight <18.5 kg/m 2 - 0, Normal weight 18.5-24.9 kg/m 2 -1, Overweight 25-29.9 kg/m 2 -2, Obese ≥ 30 kg/m 2 - 3 Intervention | Group | Group- A (Control Group of 20 Patients) | Group-B (Trial Group of 20 Patients) | | Drug | Shatpushpa taila nasya | Shatpushpa taila nasya along with shatpyshpa choorna orally | | Route | Nasal route | Nasal and orally | | Dose | 2 drops in each nostril, 7 days before LMP | Nasya :-2 drops in each nostril, 7 days before LMP Choorna :- 3 gm BD with luke warm water | | Duration | For 2 consecutive cycle | For 2 consecutive cycle | | Follow up | After completion of each menstruation for 2 Consecutive Cycle | After completion of each menstruation for 2 Consecutive Cycle | | Final followup | In 3rd month (without medicine ) | In 3rd month (without medicine) | Study duration Total 3 months (2 months for treatment & after 1 month final follow up) Follow up Followup during treatment : Each menstrual cycle for 2 consecutive cycle Final follow up : on 3rd menstrual cycle Laboratory Investigations 1)CBC 2)U.S.G (PELVIS) |