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CTRI Number  CTRI/2020/04/024739 [Registered on: 20/04/2020] Trial Registered Prospectively
Last Modified On: 10/04/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial on Ayurvdic therepy in delayed and scanty menses  
Scientific Title of Study   A Randomized open label comparative clinical study of Shatapushpa Kalpa with Shatapushpa taila matra basti and Tilashelukaravi kwatha in the management of Artava Kshaya 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Poonam Kumari 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Prasuti Tantra avum Stri Roga, National Institute of Ayurveda, Near Jorawar singh gate, Amer road,Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9779866814  
Fax    
Email  azadpoo77@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Hetal H Dave 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti Tantra avum Stri Roga, National Institute of Ayurveda, Near Jorawar singh gate, Amer road,Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9251758867  
Fax    
Email  hetaldave2406@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hetal H Dave 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti Tantra avum Stri Roga, National Institute of Ayurveda, Near Jorawar singh gate, Amer road,Jaipur

Jaipur
RAJASTHAN
302002
India 
Phone  9251758867  
Fax    
Email  hetaldave2406@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda near Jorawar Singh Gate Amer road Pin code : 302002  
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Department of prasuti tantra avum stri roga National institute of Ayurveda near jorawar singh gate amer road Jaipur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Poonam Kumari  National Institute of Ayurveda  Department of Prasuti Tantra avum Stri Roga National Institute of Ayurveda Jorawar singh gate Amer road Jaipur 302002
Jaipur
RAJASTHAN 		 9779866814

azadpoo77@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N915||Oligomenorrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Shatapushpa Kalpa and Shatapushpa taila   Dose of Shatapushpa kalpa- on first day of menses starting with 6 gm of Shatapushpa churna with Ghrita , by gradually increasing 1gm./day and continuing it till 14th day of cycle, after that gradually decreasing 1 gm./day till it reaches up to 6 gm of dose. Dose of Matra basti- 60ml for 7 alternate days, starting from 14th day of menstrual cycle. Route of administration of Shatapushpa Kalpa : Oral Route of administration of Basti : Per Rectum Duration for kalpa and basti : 2 months 
Comparator Agent  Tilshelukaravi kwatha  Dose of kwatha-:40 ml BD (Kwatha will be prepared by 20 gms of kwatha churna) and will be administered empty stomach. Route of Kwatha : Oral Duration : 2 months 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Age- 15-40 years, Married/ Unmarried patients having any of following symptoms :-
1. Patient willing and able to participate in the study with written informed consent. Consent will be taken from guardian of those patient below 18 years of age.
2. Duration of flow less than 3 days with reduced quantity of flow (using less than 2 pads/day) with or without pain.
3. Interval between 2 cycles exceeding more than 35 days with or without pain.
4. Patients suffering from 2 consecutive cycles of Oligomenorrhoea and or Hypomennorhoea both.
 
 
ExclusionCriteria 
Details  1. Patients having physiological infrequent menstruation.
2. Pregnant women.
3. Lactating mothers
4. Women taking OCPs.
5. Patients suffering from any systemic diseases.
6. Patients having any organic pathology of uterus and adnexa.
7. Hb. level less than 7 gm%.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To regularize menstrual cycle with normal flow of menstrual bleeding.
 		 after 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in associated features like painful menstruation etc.  after 8 weeks. 
 
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 
Date of First Enrollment (India)   01/05/2020 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Physiological changes and development occurs right from birth but markedly during the age of puberty. Due to increased physical and emotional stress in routine life style of women alters the physiology of “Hypothalamus-Pituitary-Ovarian-Uterine axis.” This condition may lead to many gynecological problems. Among all gynecological problems, the most common one menstrual problem is Artava Kshaya being more common. On reviewing our Ayurvedic classics we found that “Artava Kshaya” is not explained as a disease in any texts where as it has been described very systematically as a symptom of so many gynecological disorders in many classics.

Artava Kshaya has been explained by Acharya Sushruta - In this condition, menstruation is delayed, menstrual blood is scanty & associated painful menstruation. Artava Kshaya has also been mentioned in Astha Artava Dushtis as Ksheen Artava . In allopathic science Lakshana of Artava Kshaya can be correlated with certain menstrual disorders as follows :

Yathochita kala adarshanam as Irregular menses or Oligomenorrhoea

Alpata as Hypomenorrhoea

Yonivedana as Dysmenorrhoea

So when we compare the disease Artava Kshaya with the modern medical science Oligomenorrhoea and Hypomenorrhoea can be correlated on the basis of its signs & symptoms.

Rationality of Drug : 

Acharayas has mentioned that the Artava is Agneya in nature and Achrayas also mentioned the concept of “Samanayam Vridhikarnam” . In line of treatment of Artava Kshaya, Acharaya Sushruta has mentioned Samshodhana and use of Agneya Dravyas . So in this study agneya dravyas will be used which will work by the Vridhi of Samaandharmi Artava. Shatapushpa to be used in study is Tikta & Katu in rasa, Ushna in Virya, has laghu-teekshna guna, vatashamaka and also been mentioned to have property Ritupravrtini. 

On pharmacological screening Shatapushpa is found to have antispasmodic, antioxidant, 

antibacterial, antidiabetic and anticancer activities.

Tilashelukaravi  are having Artavapravartaka properties like they are Ushna Virya, Vatashamka , Kaphashamka due to which they will have better action on Rajorodha and will lead to Artavapravartana. Along with all this tila also have Vednasthapana property which will work on painful menstruation. On pharmacological screening Tila is found to have antioxidant , hepatoprotective activities. Shelu is found to have  Immunomodulator, antidiabetic, hepatoprotective, antioxidant activities. Karvi is found to have antispasmodic, analgesic, anti inflammatory activities

The procedure that is chosen to administer Shatapushpa Taila in this trial is Matra Basti. Acharya Charaka described Matra Basti as Sarvkala Niratyaya that is it can be given any time without any complications. It is mentioned to have Balya, Brihmana, Vataroganuta5 properties

 
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