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CTRI Number  CTRI/2025/04/084411 [Registered on: 08/04/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Use of Shatapushpa churna and Pathadi kwath in Aartavakshaya (PCOD) 
Scientific Title of Study   A study on Viruddha Aahara Janya Aartavakshaya w.s.r. to PCOD and its management through Shatapushpa churna and Pathadi kwath 
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 Swarnima Koshle  
Designation  PG Scholar 
Affiliation  Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010 
Address  Department of Agadtantra evum vidhi ayurveda Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010

Raipur
CHHATTISGARH
492010
India 
Phone  7470943219  
Fax    
Email  swarnimakoshle@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S R Inchulkar 
Designation  Professor & HOD of Agadtantra evum vidhi ayurveda govt. Ayurvedic College Raipur 
Affiliation  Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010 
Address  Department of Agadtantra evum vidhi ayurveda Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9425215318  
Fax    
Email  sinchulkar@yahoo.in  
 
Details of Contact Person
Public Query
 
Name  Dr S R Inchulkar 
Designation  Professor & HOD of Agadtantra evum vidhi ayurveda govt. Ayurvedic College Raipur 
Affiliation  Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010 
Address  Department of Agadtantra evum vidhi ayurveda Shri NPA Govt. Ayurvedic College G.E. road Raipur 492010

Raipur
CHHATTISGARH
492010
India 
Phone  9425215318  
Fax    
Email  sinchulkar@yahoo.in  
 
Source of Monetary or Material Support  
Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 
 
Primary Sponsor  
Name  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 
Address  Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 
Type of Sponsor  Government medical college 
 
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 Swarnima Koshle  Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh  OPD no.16 Department of Stri Roga & Prasutitantra Shri Khudadad Dungaji Government Ayurved Hospital Raipur Chhattisgarh
Raipur
CHHATTISGARH 
7470943219

swarnimakoshle@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:E282||Polycystic ovarian syndrome. Ayurveda Condition: ARTAVAKSHAYAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Shatapushpa churna , Reference: Kashyap samhita kalpadhyay, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Honey), Additional Information: Pathya Apathya
(2) Medicine Name: Pathadi kwath, Reference: Sushruta samhita sharirsthan, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 50(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Pathya Apathya
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Patients agree for these study and ready to grant their written consent.
2. Patients between 18 to 40 female years of age will be selected.
3. Patients with clinical features of Aartavakshaya as mentioned in Ayurvedic
texts.
4. Patients with symptoms of PCOD by modern view.
5. USG diagnosed and/or laboratory diagnosed cases of PCOD. 
 
ExclusionCriteria 
Details  1. Patients having new growths like (benign/malignant), malignancies, polyps and
fibroids in the reproductive organs.
2. Patients suffering from uncontrolled hypertension.
3. Any systemic major illness like – Tuberculosis, incompensatory heart/liver/renal diseases.
4. Patients having sever infectious disease.
5. Patients having malignancies (in any system).
6. Patients having congenital anomalies of reproductive system. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduce the symptoms of Aartavakshaya  8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
improve the quality of life  90 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/05/2025 
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="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  

INTRODUCTION

         Ayurveda is very ancient science. The word ‘Ayurveda’ is composed of two words ‘Ayu’ means life and ‘Veda’ means knowledge, wisdom and science. The one, which provides the knowledge of life, is called Ayurveda. According to Ayurveda good health is based on the proper balancing of Dosha, Dhatu, Mala.1

      Ikz;kstua pkL; LoLFkL; LokLF;j{.ka vkrqjL; fodkj iz’keua pA

                                                                                                                        (p-lw-30/26)

         The purpose of Ayurveda is to maintain the health of a healthy individual and to cure the disease of the patients.2 Ayurveda deals with comfort and discomfort, physiological, pathological and psychological aspects of life. It is a science of humans physical & mental health and disease.3

       vxnrU=a uke liZdhVywrkew”kdkfnn”Vfo”kO;atukFkZa fofo/kfo”kla;ksxksi’keukFkZa pA

                                                                                                                          (lw-lw-1/14)

          Agadatantra is one of the incredible branch of indigenous branches derived from the ancient sciences of Astang Ayurveda.4  Agadatantra deals with signs and symptoms and also the management of poisoning, resulting from the bite of snakes, insects and worms, spider etc. as well as from the combination of various other poisons.5  The word Agadatantra is derived from two words ‘Agad’ and ‘Tantra’. Agad  itself is derived from word ‘Gada’. The word Gada has two manings, one is disease and other is poison. Agad means anything that conquers a poison and Agadatantra is the system of knowledge for conquering poisons.6

           Viruddha Aahara is incompatible diet. It is referred in terms of food to food interaction or food processing interaction which develops toxicity because of antagonism. Ayurved clearly defines good food habits along with certain diet and its bad combination that creat Toxicity in the body tissues. Many people are consuming incompitable food like Junk food, fast food, deep fried food etc in current era unknowingly.7

                           ;r~ fdfUpn~ nks”kekL=kO; u fugZjfr dk;r% A

           vkgkjtkra rr~ loZefgrk;ksii|rs AA

                                  (p-lw- 26/85)

             According to Acharya Charaka all kinds of food which aggravate (increase)  the Dosha but do not expel them out of the body and when all of them become unstable or unhealthy for the body is called Viruddha. It is of 18 type and produces various types of disease.8

                                

                                  ;fRdfP´íks”keqRDGs’; Hkqäa dk;ké fugZjsr~ A

               jlkfn”o;FkkFkZa ok rf}dkjk; dYirs AA

                                      (lw-lw-20/20)

According to Acharya Sushruta Viruddha Aahara not only provokes the Dosha but they also aggravetes the Dhatu.9

                                        fo:)efi pkgkja fo|kf}”kxjksiee~ AA

                                                                                               (v-g`-lw-7/29)

According to Acharya Vagbhata Viruddha Aahara is equivalent to Vish (Sthavar, Janagam) and Garavish (Kritrim vish).10

           As per the Ayurvedic perspective, to digest the food properly, Jatharagni is necessary. It creates Aahar Rasa, which nourishes all of the Dhatu. All Dhatu have its own Agni called Dhatwagni which work at tissue level.11 Continuous intake of Viruddha Aahara leads to vitiation of Agni. There fore vitiated Jatharagni does not digest even the lightest of food substances resulting in Agnimandya (Indigestion / Ajirna). Agnimandya is source of several diseases. This undigested food material turns source and acts like a poison, which is called Ama visha. The resulting Aahara Rasa will not properly nourish Dhatus.12  It vitiates the Rasa Dhatu which leads to Dhatwagnimandya (Reduced metabolism) and Srotorodha ( Obstruction in body channels ). Artava is Updhatu of Rasa Dhatu. When the Dhatwagni of Rasa dhatu is deranged, there is decreased formation of  Updhatu Artava i.e. and causes Aartavakshaya.

Acharya Sushruta has explained the symptom of Aartavakshaya  -

         vkrZo{k;s ;FkksfpRRkdkykn’kZueYirk ok ;ksfuosnuk p A

                                       (lq-lw-15/12)

In the disease of  Aartavakshaya the menstruation does not appear in its appropriate time or is delayed (Inter menstrual period is prolonged), scanty and does not lasts for three days. There is also pain in vaginal region (i.e. pelvis). Chakrapani opines that this pain is due to aggravate of Vayu causes loss of Aartava which fills this region.14

Aartavakshaya is caused due to the involvement of Vata and Kapha Dosha which leads to Marga Avrodha of Artava Vaha Srotas.15 According to Modern science Aartavakshaya can be co-related with Poly cystic ovarian disease. It is a heterogeneous, multisystem endocrinopathy in woman of reproductive age with the ovarian expression of various metabolic disturbance and a wide spectrum of clinical features such as oligomenorrhoea and/or hypomenorrhoea, hirsutism and obesity associated with enlarged poly cystic ovaries.

In modern medical science, the treatment for PCOD is based on hormonal therapy which may have its own complications on prolonged duration of therapy where as in Ayurveda science there is an effective and safe therapy is available. In Aartavakshaya the line of treatment mentioned is use of agneya drugs which have the properties of Amla and Katu rasa, Ushna vipaka and Guru guna. Satapushpa is specialy idicated in Kashyap Samhita for the treatment of scanty menstruation, oligomenorrhoea and infertility problems and Pathadi kwath described by Acharya Sushruta. Pathadi kwath shows properties like Ushana & Tikshan. Hence, these formulations may be  helpful in the management of Viruddha Aahara janya Aartavakshaya w.s.r. to PCOD

NEED OF STUDY

·         In today,s modern era, due to lack of awareness about correct balanced food combination people blindly follow the Viruddha Aahara i.e. unhealthy food habits like Junk food, Fast food, deep fried food etc. Poly cystic ovarian disease is a common endocrine disorder in women of reproductive age group. Incidence of this disease is increasing now a days because of changing sedentary lifestyle, psychological stress, and excessive intake of unhealthy food habits (Viruddha aahara). It is one of the leading causes of infertility. Risk factors include insulin resistance, cardiovascular disease, hypercholestremis & osteoporosis, obesity. Patients of PCOD are increasing day by day in gynaecological OPDs. As per Ayurvedic view, clinical picture of PCOD seems to be vata-kapha dosha and Aartava-vaha srotasadushti . It can also be correlated with Aartavakshaya like Oligomenorrhoa & Hypomenorrhoea if predominance of Vata is there.

·         The Global prevalence rate of PCOD is found 7% among reproductive age group of female population in world wide. In India it is about 10% in reproductive age group of female population. Its prevalence rate is increasing now a day due to sedentary life style, psychological stress, and excessive intake Viruddha Aahara (unhealthy food habits). The PCOD has adverse effect on the reproductive life of woman. Infact one of the major cause of infertility in Indian females is found to be PCOD. To fulfill the expectation from the Ayurvedic field and to find out more effective and safe therapy for Viruddha Aahara Janya Aartavakshaya w.s.r. to PCOD, this topic is selected for research work.

·        The treatment of the PCOD in morden system of medicine is mainly dependent on hormonal therapy and other drugs which may have its own complications on prolonged duration of therapy likewise weight gain, hormonal imbalance etc. Where as Ayurvedic treatment is comparatively safe, having less or no complications, and has high curative rate. In Kashyap samhita (Shatapushpa-shatavari kalpadhyaya 5/19) the drug Shatapushpa is specially prescribed for treatment of menstrual disorders associated with symptoms while Acharya Sushruta has described Pathadi Kwath (Shukra-shonita-shudhhi shariradhyaya 2/16) for the same purpose. The agneya property of the Pitta dosh increases due to the Ushana, Tikshana, Lekhana and Pchana guna of  Pathadi Kwath. This may increase the duration of menses and the amount of bleeding. The ingredients of  Shatapushpa and Pathadi Kwath are easily available herbal drugs having minimum cost and safe for human being therefore both of item are selected for the clinical management of PCOD in this study.



 
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